Efficacy and Safety of Peginesatide in the Treatment of Anemia in Patients With Chronic Kidney Disease
The purpose of this study is to evaluate the ability of peginesatide to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).
Chronic Kidney Disease
Chronic Renal Failure
Pure Red Cell Aplasia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study to Investigate the Efficacy and Safety of Peginesatide in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease|
- Proportion of participants who increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit of the target range in the absence of red blood cell transfusion in the previous 28 days by Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Number of red blood cell transfusions during the 26 week pre-treatment period (prior to enrollment) and during 13- and 26 week intervals during the study. [ Time Frame: 26 weeks prior to enrollment to end of study ] [ Designated as safety issue: No ]
- Time to initial achievement of hemoglobin greater than or equal to the lower limit of the target range in the absence of red blood cell transfusions in the previous 28 days. [ Time Frame: While On Study ] [ Designated as safety issue: No ]
- Proportion of participants with red blood cell transfusions during the 26 week pre-treatment period (prior to enrollment) and during 13- and 26 week intervals during the study. [ Time Frame: 26 weeks prior to enrollment to end of study ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Peginesatide dose administered subcutaneously once every 4 weeks. The frequency of each injection and the dose may be adjusted based on the participant's hemoglobin response and the ability to maintain a hemoglobin level in the range of 10.0-12.0 g/dL.
This is an open-label treatment study; all participants enrolled into the study will receive peginesatide. Participants with CKD with documented antibody-mediated PRCA, a hemoglobin level < 10 grams per deciliter (g/dL) (without an erythropoiesis stimulating agent [ESA]), and who meet the eligibility criteria will be enrolled. It is anticipated that up to 40 patients will be enrolled in the trial.
The first group of 5 participants will receive a starting dose of 0.05 milligram per kilogram (mg/kg), administered every 4 weeks (for this study, 1 month is defined as 4 weeks). Based on the assessment of the dose response in this initial group of 5 participants, the starting dose in subsequent participants may be increased. The dose and frequency of peginesatide will be modified based on hemoglobin response in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL.
|Derby, United Kingdom|
|London, United Kingdom|
|Study Director:||Medical Director||Takeda|