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

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00146224

Purpose

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	Intervention	Phase
Nephrology	Drug: Epoetin alfa RB Drug: Epoetin alfa DT	Phase III

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin BaseLine Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
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

Further study details as provided by Amgen:

Primary Outcome Measures:

Change in Heloglobin level between the screening period and the evaluation period [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Ratio of weekly dose at the evaluation period to the weekly dose at baseline [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average Epoetin alfa dose over evaluation period [ Time Frame: evaluation period (weeks 21 - 28) ] [ Designated as safety issue: No ]
Change from baseline dose at each measurement timepoint [ Time Frame: entire study ] [ Designated as safety issue: No ]
Epoetin alfa seroreactivity [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
Subject incidence, nature and severity of adverse events [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
Hemoglobin variability [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
changes from baseline laboraotry and vital sign parameters [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
Change from baseline Hb at each measurement timepoint [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
Maintaining Hemoglobin within range at each measurement timepoint [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	420
Study Start Date:	September 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Epoetin alfa RB: Active Comparator	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.
Epoetin alfa DT: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146224

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050113
Study First Received:	September 6, 2005
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00146224
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

anemia
chronic kidney disease, CKD
hemodialysis
epoetin
Epogen®

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Benzocaine

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009