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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210743
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 23, 2011
Ortho Biotech Products, L.P.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

September 13, 2005
September 21, 2005
May 23, 2011
May 2004
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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.
Same as current
Complete list of historical versions of study NCT00210743 on Archive Site
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.
Same as current
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Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.
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)
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
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anemia
  • Kidney Diseases
Drug: epoetin alfa
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2005
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Products, L.P.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP