Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

Phase 3

Completed

• Conditions: Nephrology
• Interventions: Drug: Epoetin alfa RB; Drug: Epoetin alfa DT

• Registration Number: NCT00146224
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization

Exclusion Criteria

• Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epoetin alfa RB	Epoetin alfa RB	-
Epoetin alfa DT	Epoetin alfa DT	-

Primary Outcome Measures

Name	Time	Method
Ratio of weekly dose at the evaluation period to the weekly dose at baseline	Entire Study
Change in Heloglobin level between the screening period and the evaluation period	Entire Study

Secondary Outcome Measures

Name	Time	Method
Change from baseline Hb at each measurement timepoint	Entire Study
Maintaining Hemoglobin within range at each measurement timepoint	Entire Study
Average Epoetin alfa dose over evaluation period	evaluation period (weeks 21 - 28)
Change from baseline dose at each measurement timepoint	entire study
Epoetin alfa seroreactivity	entire study
Subject incidence, nature and severity of adverse events	entire study
Hemoglobin variability	entire study
changes from baseline laboraotry and vital sign parameters	entire study