Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.

Study Description

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Brief Summary:

The purpose of this study is to evaluate the hemoglobin response rate in subjects with anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRIT®) every 2 weeks

Condition or disease	Intervention/treatment	Phase
Anemia; Kidney Diseases	Drug: epoetin alfa	Phase 2

Detailed Description:

This is a prospective study in non-dialysis subjects with anemia associated with chronic kidney disease. Subjects will be enrolled from multiple centers in the United States. The primary objective of the study is to evaluate hemoglobin response rate. The secondary objectives include evaluating the time to when hemoglobin responds, indicated by the results of the hemoglobin blood levels, the change in hemoglobin over time, the transfusion requirements and change in quality of life measurements. These measurements asks for the subjects views about how one feels, activity and energy level, etc. The subjects are administered study drug every 2 weeks through Study Week 27 unless dosing is held or the subject withdraws from the study. Each injection of study drug should not exceed 1 ml in volume.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	67 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label, Clinical Evaluation of the Initiation of Every 2 Week Epoetin Alfa (PROCRIT)in the Treatment of Subjects With the Anemia of Chronic Kidney Disease (CKD)
Study Start Date :	May 2004
Actual Study Completion Date :	October 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. The primary endpoint is the number of subjects who achieve a hemoglobin response after receiving PROCRIT every 2 weeks. Hemoglobin response is defined as achieving a target hemoglobin range of 11-12 g/dL for at least 2 consecutive weeks by Week 28.

Secondary Outcome Measures :

1. The secondary endpoints include: the time to a hemoglobin response, the number of subjects achieving a 1 g/dL rise in hemoglobin, change in quality of life measurements, and the total study drug dose up to the time of response.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Subjects with chronic kidney disease and a glomerular filtration rate within 10-60 ml/min/1.73m2 with no expected need for dialysis during the study
• subjects with a hemoglobin less than 11 g/dL
• subjects who have not received erythropoietic agents within 6 weeks before study entry
• female subjects, with a reproductive potential, must have a negative urine pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

• Subjects with poorly controlled high blood pressure (hypertension) - systolic > 150 mm Hg or diastolic > 100 mm Hg
• known hypersensitivity to human albumin and/or mammalian cell-derived products
• subjects receiving dialysis
• subjects with a ferritin level < 50 ng/mL, Transferrin Saturation < 20%
• subjects receiving chemotherapy for cancer within 1 month prior to study start or expected during study participation
• Pregnancy or lactation.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Investigators

Study Director:	Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

An Open-Label, Clinical Evaluation of the Initiation of Every 2 Week PROCRIT (epoetin alfa) in the Treatment of Subjects with the Anemia of Chronic Kidney Disease 

Publications of Results:

Benz R, Schmidt R, Kelly K, Wolfson M. Epoetin alfa once every 2 weeks is effective for initiation of treatment of anemia of chronic kidney disease. Clin J Am Soc Nephrol. 2007 Mar;2(2):215-21. Epub 2007 Jan 10.

ClinicalTrials.gov Identifier:	NCT00210743 History of Changes
Other Study ID Numbers:	CR004600
First Posted:	September 21, 2005
Last Update Posted:	May 23, 2011
Last Verified:	April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Anemia; chronic kidney disease; erythropoetin, Epoetin alfa; erythropoetin recombinant; pre-dialysis

Additional relevant MeSH terms:

Anemia; Kidney Diseases; Renal Insufficiency, Chronic; Hematologic Diseases	Urologic Diseases; Renal Insufficiency; Epoetin Alfa; Hematinics