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)
1 other identifier
interventional
67
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMay 23, 2011
April 1, 2010
September 13, 2005
May 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.2215/CJN.02590706. Epub 2007 Jan 10.
PMID: 17699416RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2004
Study Completion
October 1, 2005
Last Updated
May 23, 2011
Record last verified: 2010-04