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Clinical Trial Details

Trial ID: L1057
Source ID: NCT00337935
Associated Drug: Epoetin Alfa
Title: 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.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00337935/results
Conditions: Renal Failure , Chronic|Anemia
Interventions: DRUG: Epoetin Alfa|OTHER: Standard of care
Outcome Measures: Primary: Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks), Week 0 to Week 26 | Secondary: The Number of Patients Achieved a Hemoglobin Response., 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, Week 0 to Week 26|Time to Hemoglobin Response, 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., Week 0 to Week 26
Sponsor/Collaborators: Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Collaborators: Ortho Biotech Clinical Affairs, L.L.C.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 157
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-07
Completion Date: 2009-07
Results First Posted: 2013-05-13
Last Update Posted: 2013-05-13
Locations:
URL: https://clinicaltrials.gov/show/NCT00337935