PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Detailed Description
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A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

Official Title
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A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Extended Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, With the Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease

Conditions
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Anemia, Renal Diseases

Intervention / Treatment
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* Drug: epoetin alfa
* Drug: epoetin alfa
* Drug: epoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) >=15 mL/min per 1.73 m2 and <60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization History of increase in hemoglobin after the initial dose Stable dose of epoetin alfa given once-weekly before randomization. Exclusion Criteria: Uncontrolled hypertension Iron deficiency iron overload severe congestive heart failure Active infection Recent heart attack, Stroke or blood clot.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks | Drug: epoetin alfa<br>* Continue pre-study once weekly dose of epoetin alfa for 36 weeks<br>|
| Experimental: 003<br>epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk | Drug: epoetin alfa<br>* Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk<br>|
| Experimental: 002<br>epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks | Drug: epoetin alfa<br>* Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment |  | from baseline (Week 1) to the last 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL) |  | Weeks 13-37 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Reduction in the number of erythrocytes, Hemoglobin low level, Red blood cell deficiency, Procrit, Epoetin alfa, Chronic kidney disease