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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nephrology

Intervention: Epoetin alfa RB (Drug); Epoetin alfa DT (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Ratio of weekly dose at the evaluation period to the weekly dose at baseline

Change in Heloglobin level between the screening period and the evaluation period

Secondary outcome:

Change from baseline Hb at each measurement timepoint

Maintaining Hemoglobin within range at each measurement timepoint

Average Epoetin alfa dose over evaluation period

Change from baseline dose at each measurement timepoint

Epoetin alfa seroreactivity

Subject incidence, nature and severity of adverse events

Hemoglobin variability

changes from baseline laboraotry and vital sign parameters

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

FDA-approved Drug Labeling

Starting date: September 2005
Last updated: February 25, 2010

Page last updated: August 23, 2015

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