| Primary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 | The following participants will be considered to have met the primary endpoint:
- Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18.
- Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit.
- Participants who have a non-study intervention prior to Week 18.
- Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
| | Posted | | Count of Participants | | Participants | | Week 3 to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
| | | Title | Denominators | Categories |
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| | 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 |
|---|
| | Cochran-Mantel-Haenszel | | 0.0143 | | Odds Ratio (OR) | 0.51 | | | 2-Sided | 95 | 0.30 | 0.87 | | | | | Other | | | | | | | | |
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| Secondary | Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Nonstudy Intervention is defined as any of the following:
- Initiation of erythropoietin for any reason
- Blood transfusion
- IV iron
- Prescribed use of oral iron
| Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Mean | Standard Deviation | g/dL | | Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention | Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention. | Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Count of Participants | | Participants | | Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants Who Received Nonstudy Intervention | Intervention is defined as any of the following:
- Initiation of erythropoietin for any reason
- Blood transfusion
- IV iron
- Prescribed use of oral iron
| Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Count of Participants | | Participants | | Baseline to week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention | Intervention is defined as any of the following:
- Initiation of erythropoietin for any reason
- Blood transfusion
- IV iron
- Prescribed use of oral iron
| Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Count of Participants | | Participants | | Baseline to week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively | Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Number | 95% Confidence Interval | Days | | Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants Requiring a Blood Transfusion | Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial. | Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Count of Participants | | Participants | | Baseline to week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Day 7 are included. | Posted | | Count of Participants | | Participants | | Baseline to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 2 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 3 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 3 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 6 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 9 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 9 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 12 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 15 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 15 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Only participant with both a baseline and at least one post baseline value at Week 18 are included. | Posted | | Count of Participants | | Participants | | Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively. | | Posted | | Number | 95% Confidence Interval | Days | | Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively. | Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Number | 95% Confidence Interval | Days | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Correlation of Change in Hemoglobin With Baseline Hepcidin Level | For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively. | Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Mean | Standard Deviation | g/dL | | Baseline to Week 18. | | | | ID | Title | Description |
|---|
| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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| Secondary | Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary. | Only subjects who completed the study from the Modified intention to treat (mITT) population. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline to Week 18 | | | | ID | Title | Description |
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| OG000 | Injectafer | 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer | | OG001 | Normal Saline | Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline |
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