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

NCT ID: NCT00146224

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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Nephrology

Keywords

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anemia chronic kidney disease, CKD hemodialysis epoetin Epogen®

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Epoetin alfa RB

Group Type ACTIVE_COMPARATOR

Epoetin alfa RB

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Epoetin alfa DT

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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United States

References

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Lei L, Olson K. Evaluating statistical methods to establish clinical similarity of two biologics. J Biopharm Stat. 2010 Jan;20(1):62-74. doi: 10.1080/10543400903115082.

Reference Type RESULT
PMID: 20077249 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_05_EPO_20050113.pdf

To access clinical trial results information click on this link

http://www.epogen.com/

FDA-approved Drug Labeling

Other Identifiers

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20050113

Identifier Type: -

Identifier Source: org_study_id