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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00146224

Collaborator

(none)

420

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Nephrology	Drug: Epoetin alfa RB Drug: Epoetin alfa DT	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Epoetin alfa RB	Drug: Epoetin alfa RB Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Experimental: Epoetin alfa DT	Drug: Epoetin alfa DT Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.

Arm

Intervention/Treatment

Active Comparator: Epoetin alfa RB

Drug: Epoetin alfa RB

Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.

Experimental: Epoetin alfa DT

Drug: Epoetin alfa DT

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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