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This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C.E.R.A. | Experimental | Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period | The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0. | EEP (Week 17 to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period | Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP. | SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agadir | 70000 | Morocco | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965694 | Derived | Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10. |
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Of 202 participants, 8 participants did not complete the stability verification period (SVP) of 4 weeks. Overall, 194 participants entered dose titration period (DTP) of 16 weeks.
A total of 202 participants were enrolled in this study conducted from 12 February 2009 to 25 October 2010 at 28 study sites in Morocco.
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| ID | Title | Description |
|---|---|---|
| FG000 | C.E.R.A. | Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | C.E.R.A. | Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period | The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0. | The per-protocol (PP) population included all participants from the intention-to-treat (ITT) population, who fulfilled inclusion/exclusion criteria as per the study protocol. A total of 123 participants were included in the PP population. | Posted | Number | 95% Confidence Interval | Percentage of participants | EEP (Week 17 to Week 24) |
|
Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C.E.R.A. | Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
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|
| Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP | Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24. | EEP (Week 17 to Week 24) |
| Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP | Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24. | EEP (Week 17 to Week 24) |
| Number of Participants With Any Adverse Events or Serious Adverse Events | An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly. | Up to Week 52 |
| Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP | Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. | DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) |
| Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase | Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported. | Up to Week 52 |
| Mean Hemoglobin Levels Over Time | The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Hematocrit Levels Over Time | The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Albumin Levels Over Time | The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean White Blood Cells and Thrombocytes Over Time | The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Phosphate and Potassium Levels Over Time | The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time | The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean C-Reactive Protein Levels Over Time | The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Ferritin Levels Over Time | The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Transferrin Saturation Levels Over Time | The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Change From Baseline in Pulse Rate Over Time | Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48). | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Change From Baseline in Blood Pressure Over Time | Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48). | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
| Mean Change From Baseline in Weight Over Time | Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48). | Week 16 and Week 48 |
| Casablanca |
| 20000 |
| Morocco |
| Casablanca | 20100 | Morocco |
| Casablanca | 21000 | Morocco |
| FÉS | 30000 | Morocco |
| Khouribga | 23000 | Morocco |
| Marrakesh | 40000 | Morocco |
| Méknés | 50300 | Morocco |
| Rabat | 10150 | Morocco |
| Rabat | 62001 | Morocco |
| Salé | 15045 | Morocco |
| Tangier | 90000 | Morocco |
| refused treatment/withdrew consent |
|
| Blood transfusion |
|
| Insufficient therapeutic response |
|
| Failure to return |
|
| Other - Reasons |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|
| Secondary | Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period | Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP. | ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0. | Posted | Mean | Standard Deviation | g/dL | SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24) |
|
|
|
| Secondary | Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP | Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24. | ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0. | Posted | Number | 95% Confidence Interval | Percentage of participants | EEP (Week 17 to Week 24) |
|
|
|
| Secondary | Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP | Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24. | ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0. | Posted | Mean | Standard Deviation | Days | EEP (Week 17 to Week 24) |
|
|
|
| Secondary | Number of Participants With Any Adverse Events or Serious Adverse Events | An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. | Posted | Number | Participants | Up to Week 52 |
|
|
|
| Secondary | Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP | Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. | ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0. | Posted | Number | Percentage of participants | DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) |
|
|
|
| Secondary | Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase | Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. | Posted | Number | Number of RBCs transfusion | Up to Week 52 |
|
|
|
| Secondary | Mean Hemoglobin Levels Over Time | The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | g/dL | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Hematocrit Levels Over Time | The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Albumin Levels Over Time | The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not. Out of 194, one participant was excluded from the ITT population due to missing hemoglobin measurement and C.E.R.A medication after Week 0. | Posted | Mean | Standard Deviation | g/L | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean White Blood Cells and Thrombocytes Over Time | The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Phosphate and Potassium Levels Over Time | The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | milimole/L | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time | The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | micromole/L | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean C-Reactive Protein Levels Over Time | The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | miligrams/L | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Ferritin Levels Over Time | The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | mcg/L | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Transferrin Saturation Levels Over Time | The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | Percentage of Transferrin Saturation | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Change From Baseline in Pulse Rate Over Time | Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48). | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | beats per minute | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Change From Baseline in Blood Pressure Over Time | Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48). | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | millimeter of mercury | Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 |
|
|
|
| Secondary | Mean Change From Baseline in Weight Over Time | Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48). | Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by 'n'. | Posted | Mean | Standard Deviation | kilogram | Week 16 and Week 48 |
|
|
|
| 19 |
| 194 |
| 15 |
| 194 |
| Cardiac disorder | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Drug effect decreased | General disorders | MedDRA 13.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Hb at Week 24 (n = 180) |
|
| Hb at Week 32 (n = 177) |
|
| Hb at Week 40 (n = 162) |
|
| Hb at Week 48 (n = 168) |
|
| Title | Measurements |
|---|---|
|
| HCT at Week 24 (n = 180) |
|
| HCT at Week 32 (n = 177) |
|
| HCT at Week 40 (n = 163) |
|
| HCT at Week 48 (n = 170) |
|
| Title | Measurements |
|---|---|
|
| Albumin at Week 24 (n = 128) |
|
| Albumin at Week 32 (n = 116) |
|
| Albumin at Week 40 (n = 108) |
|
| Albumin at Week 48 (n = 147) |
|
| Title | Measurements |
|---|---|
|
| WBCs at Week 24 (n = 138) |
|
| WBCs at Week 32 (n = 129) |
|
| WBCs at Week 40 (n = 123) |
|
| WBCs at Week 48 (n = 153) |
|
| Thrombocytes at Week 0 (n = 194) |
|
| Thrombocytes at Week 8 (n = 153) |
|
| Thrombocytes at Week 16 (n = 137) |
|
| Thrombocytes at Week 24 (n = 138) |
|
| Thrombocytes at Week 32 (n = 129) |
|
| Thrombocytes at Week 40 (n = 123) |
|
| Thrombocytes at Week 48 (n = 153) |
|
| Title | Measurements |
|---|---|
|
| Phosphate at Week 24 (n = 130) |
|
| Phosphate at Week 32 (n = 116) |
|
| Phosphate at Week 40 (n = 110) |
|
| Phosphate at Week 48 (n = 148) |
|
| Potassium at Week 0 (n = 194) |
|
| Potassium at Week 8 (n = 139) |
|
| Potassium at Week 16 (n = 131) |
|
| Potassium at Week 24 (n = 130) |
|
| Potassium at Week 32 (n = 117) |
|
| Potassium at Week 40 (n = 110) |
|
| Potassium at Week 48 (n = 146) |
|
|
| Creatinine at Week 24 (n = 130) |
|
| Creatinine at Week 32 (n = 117) |
|
| Creatinine at Week 40 (n = 110) |
|
| Creatinine at Week 48 (n = 149) |
|
| Iron at Week 0 (n = 194) |
|
| Iron at Week 8 (n = 139) |
|
| Iron at Week 16 (n = 129) |
|
| Iron at Week 24 (n = 130) |
|
| Iron at Week 32 (n = 116) |
|
| Iron at Week 40 (n = 110) |
|
| Iron at Week 48 (n = 148) |
|
| TIBC at Week 0 (n = 194) |
|
| TIBC at Week 8 (n = 137) |
|
| TIBC at Week 16 (n = 126) |
|
| TIBC at Week 24 (n = 123) |
|
| TIBC at Week 32 (n = 116) |
|
| TIBC at Week 40 (n = 110) |
|
| TIBC at Week 48 (n = 147) |
|
| Title | Measurements |
|---|---|
|
| CRP at Week 24 (n = 127) |
|
| CRP at Week 32 (n = 112) |
|
| CRP at Week 40 (n = 109) |
|
| CRP at Week 48 (n = 140) |
|
|
| Ferritin at Week 24 (n = 128) |
|
| Ferritin at Week 32 (n = 116) |
|
| Ferritin at Week 40 (n = 110) |
|
| Ferritin at Week 48 (n = 148) |
|
| Title | Measurements |
|---|---|
|
| TSAT at Week 24 (n = 123) |
|
| TSAT at Week 32 (n = 115) |
|
| TSAT at Week 40 (n = 110) |
|
| TSAT at Week 48 (n = 147) |
|
| Title | Measurements |
|---|---|
|
| Week 32 (n = 173) |
|
| Week 40 (n = 174) |
|
| Week 48 (n = 190) |
|
|
| SBP before dialysis at Week 32 (n = 181) |
|
| SBP before dialysis at Week 40 (n = 175) |
|
| SBP before dialysis at Week 48 (n = 191) |
|
| SBP after dialysis at Week 8 (n = 185) |
|
| SBP after dialysis at Week 16 (n = 181) |
|
| SBP after dialysis at Week 24 (n = 178) |
|
| SBP after dialysis at Week 32 (n = 177) |
|
| SBP after dialysis at Week 40 (n = 171) |
|
| SBP after dialysis at Week 48 (n = 187) |
|
| DBP before dialysis at Week 8 (n = 189) |
|
| DBP before dialysis at Week 16 (n = 185) |
|
| DBP before dialysis at Week 24 (n = 182) |
|
| DBP before dialysis at Week 32 (n = 181) |
|
| DBP before dialysis at Week 40 (n = 175) |
|
| DBP before dialysis at Week 48 (n = 191) |
|
| DBP after dialysis at Week 8 (n = 185) |
|
| DBP after dialysis at Week 16 (n = 181) |
|
| DBP after dialysis at Week 24 (n = 178) |
|
| DBP after dialysis at Week 32 (n = 177) |
|
| DBP after dialysis at Week 40 (n = 171) |
|
| DBP after dialysis at Week 48 (n = 187) |
|