Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0663
Source ID: NCT00680043
Associated Drug: Peginesatide
Title: Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00680043/results
Conditions: Anemia|Chronic Renal Failure|Chronic Kidney Disease
Interventions: DRUG: peginesatide|DRUG: peginesatide|DRUG: Epoetin Alfa
Outcome Measures: Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period, The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28., Baseline and Weeks 21-28 | Secondary: Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods, Weeks 1 to 28|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods, A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks., Weeks 1 to 28
Sponsor/Collaborators: Sponsor: Affymax | Collaborators: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 114
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date: 2009-08
Results First Posted: 2012-05-30
Last Update Posted: 2012-06-29
Locations: Research Facility, Irkutsk, Russian Federation|Research Facility, Krasnodar, Russian Federation|Research Facility, Krasnoyarsk, Russian Federation|Research Facility, Moscow, Russian Federation|Research Facility, Nizhniy Novgorod, Russian Federation|Research Facility, Omsk, Russian Federation|Research Facility, Petrozavodsk, Russian Federation|Research Facility, Saratov, Russian Federation|Research Facility, St. Petersburg, Russian Federation|Research Facility, Tver, Russian Federation|Research Facility, Volzhsk, Russian Federation
URL: https://clinicaltrials.gov/show/NCT00680043