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Epoetin Alfa (EPO) in Subjects With Chronic Kidney Disease (CKD)

NCT ID: NCT00156962

Last Updated: 2008-07-21

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to look at subject incidence of adverse events.

Detailed Description

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To determine whether Epoetin alfa manufactured by a roller bottle technology (Epoetin alfa RB) and Epoetin alfa manufactured by a deep tank process (Epoetin alfa DT) have a comparable safety profile when administered to patients with CKD not on dialysis.

Conditions

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Chronic Kidney Disease

Keywords

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Epogen Procrit Chronic Kidney Disease Anemia Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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 11.0 - 13.0 g/dL

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 11.0 - 13.0 g/dL

Interventions

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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 11.0 - 13.0 g/dL

Intervention Type 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 11.0 - 13.0 g/dL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients known to have tested positive at any time in the past for antibodies to erythropoietic proteins. - Systemic hematological disease (eg. sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia. - Other investigational products are excluded. - Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s). - Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study. - Pregnant or breast feeding (women of child-bearing potential must be taking adequate contraceptive precautions). - Anticipating or scheduled for a living-related kidney transplant. - Currently receiving home hemodialysis treatment. - 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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Puerto Rico United States

Related Links

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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_20040259.pdf

To access clinical trial results information click on this link

http://www.epogen.com/

FDA-approved Drug Labeling

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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NOT APPLILCABLE

Identifier Type: -

Identifier Source: secondary_id

20040259

Identifier Type: -

Identifier Source: org_study_id