A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.
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|ClinicalTrials.gov Identifier: NCT00337935|
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure , Chronic Anemia||Drug: Epoetin Alfa Other: Standard of care||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
|Experimental: Epoetin Alfa||
Drug: Epoetin Alfa
Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).
Other: Standard of care
Other Name: Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).
- Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks) [ Time Frame: Week 0 to Week 26 ]
- The Number of Patients Achieved a Hemoglobin Response. [ Time Frame: Week 0 to Week 26 ]Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL
- Time to Hemoglobin Response [ Time Frame: Week 0 to Week 26 ]Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337935
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|