| Primary | Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM after 8 weeks of Hgb maintenace therapy on Day 57. Analysis was based on "analysis of covariance (ANCOVA) with terms for treatment, prior erythropoiesis-stimulating agent (ESA) dose (low/high), post-Hemodialysis dependent (HD)/pre-AC 1 SBP, difference between post-HD/pre-AC 2 SBP and post-HD/pre-AC 1 SBP and treatment by difference in post-HD SBP between AC 1 and 2 interaction." Least square (LS) mean of 6 hour average SBP post AC2 on Day 57 and its corresponding standard error has been presented. | Intent-to-Treat (ITT)-Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Millimeters of mercury (mmHg) | | Up to 6 hours post dose on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000142.87± 3.039
- OG001143.03± 2.995
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.9694 | p-value for the difference between treatment groups were presented from ANCOVA model for the superiority assessment. | LS Mean Difference | -0.17 | | | 2-Sided | 95 | -8.80 | 8.47 | | | LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% confidence interval (CI) has been presented. | | Superiority | | |
|
| Secondary | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | The initial effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 SBP, DBP and MAP. LS mean of 6 hour average SBP, DBP and MAP post AC1 on Day 1 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 6 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin |
|
| Secondary | Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | The initial effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR. LS mean of 6 hour average HR post AC1 on Day 1 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Beats per minute | | Up to 6 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Secondary | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | The initial effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 1. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg*Hours | | Up to 24 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
|
| Secondary | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1 | The initial effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Beats per minute*Hours | | Up to 24 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Secondary | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing after AC2 on Day 57. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 DBP and MAP, difference between post-HD/pre-AC2 DBP and MAP and post-HD/pre-AC1 DBP and MAP and treatment by difference in post-HD DBP and MAP between AC1 and 2 interaction. LS mean of 6 hour average DBP and MAP post AC2 on Day 57 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 6 hours post dose on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 |
|
| Secondary | Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57 | The effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR, difference between post-HD/pre-AC2 HR and post-HD/pre-AC1 HR and treatment by difference in post-HD HR between AC1 and 2 interaction. LS mean of 6 hour average HR post AC2 on Day 57 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Beats per minute | | Up to 6 hours post dose on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin |
|
| Secondary | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg*Hours | | Up to 24 hours post dose on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
|
| Secondary | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57 | The effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. | ITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Beats per minute*Hours | | Up to 24 hours post dose on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Change From Pre-dose in SBP, DBP and MAP at Day 1 | The change from pre-dose in SBP, DBP and MAP was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. | ITT-Population. Only those participants with data available at specified time points has been presented (represented as n=X in category titles). | Posted | | Mean | Standard Deviation | mmHg | | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
|
| Secondary | Change From Pre-dose in HR at Day 1 | The change from pre-dose in HR was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. | ITT-Population. Only those participants with data available at specified time points has been presented (represented as n=X in category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Daprodustat | Blood samples were collected at indicated time points for the concentrations of daprodustat. | Pharmacokinetic Population comprised of all participants in the Safety population who had at least 1 non-missing pharmacokinetic assessment. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Metabolite GSK2391220 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2391220. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Metabolite GSK2506104 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2506104. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Metabolite GSK2487818 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2487818. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Metabolite GSK2506102 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK25206102. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Metabolite GSK2531398 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531398. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Plasma Concentrations of Metabolite GSK2531401 | Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531401. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Mean | Standard Deviation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Median | Full Range | Hours | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Secondary | Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401 | Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at specified time points has been presented (represented as n=X in the category titles). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter | | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Number of Participants With Any Serious Adverse Events (SAEs) | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. | Safety Population comprises of all randomized participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs) | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Number of participants with treatment emergent common (>=2% non-SAEs in each arm) non-SAEs has been presented. | | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Number of Participants Who Discontinued the Study Treatment | Number of participants who discontinued the study treatment due to any reason are presented. The reasons for discontinuation included adverse events, protocol specified withdrawal criteria met, physician decision and withdrawal by participant. | | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Clinical Chemistry Parameters: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin | Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and Indrt bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium | Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST | Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin | Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and indrt. bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
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| Other Pre-specified | Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium | Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
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| Other Pre-specified | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
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| Other Pre-specified | Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes | Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC) | Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr) | Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV) | Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Absolute Values for Hematology Parameter: Erythrocyte Distribution Width | Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Percentage of width | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameter: Hematocrit | Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes | Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC | Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr | Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameter: Ery. MCV | Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width | Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Percentage of width | | Baseline (Day 1) and at Days 29, 57 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Absolute Values for Electrocardiogram (ECG) Mean Heart Rate | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin |
|
| Other Pre-specified | Change From Baseline Values for ECG Mean Heart Rate | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
|
| Other Pre-specified | Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB | Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin |
|
| Other Pre-specified | Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | | | | ID | Title | Description |
|---|
| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
|
| Other Pre-specified | Absolute Values for Temperature | Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Degrees celsius | | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | | | | ID | Title | Description |
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| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Absolute Values for Pulse Rate | Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, predose) and at Day 1:3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | | | | ID | Title | Description |
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| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | Participants were randomized to receive a single intravenous (IV) dose of 100 units per kilogram (U/Kg) Epoetin alfa (Recombinant human erythropoietin) during 24-hour acute challenge 1 on Day 1. Participants discontinued their current ESA therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week Hgb maintenance period, where Epoetin alfa was administered according to local labelling and clinical practice guidelines to maintain target Hgb levels within the range of 10.0 to 11.0 g/dL. Participants received acute challenge 2 on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. |
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| Other Pre-specified | Change From Baseline Values for Vital Signs: SBP and DBP | Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | | | | ID | Title | Description |
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| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin |
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| Other Pre-specified | Change From Baseline Values for Temperature | Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Degrees celsius | | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | | | | ID | Title | Description |
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| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
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| Other Pre-specified | Change From Baseline Values for Pulse Rate | Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis | | | | ID | Title | Description |
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| OG000 | Daprodustat | Participants were randomized to receive a single oral dose of Daprodustat 24 milligrams (mg) during 24-hour acute challenge 1 (AC1) on Day 1. Participants discontinued their current erythropoiesis stimulating agent (ESA) therapy and were washed out of their ESAs for 2 weeks prior to acute challenge 1. After completion of acute challenge 1, participants entered in 8-week hemoglobin (Hgb) maintenance period, where doses of daprodustat were administered and adjusted to maintain target Hgb levels within the range of 10.0 to 11.0 grams per deciliter (g/dL). Participants received acute challenge 2 (AC2) on Day 57 with the same treatment dose administered in acute challenge 1. All participants were followed up for 14 days after acute challenge 2. | | OG001 | Recombinant Human Erythropoietin | |
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