Efficacy and Safety of Peginesatide in the Treatment of Anemia in Patients With Chronic Kidney Disease
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 patients enrolled into the study will receive AF37702 Injection. Hematologic data prior to treatment with AF37702 Injection will be compared to values obtained during treatment with AF37702 Injection (see Section 6.2).
CKD patients with documented antibody-mediated PRCA, hemoglobin level < 10 g/dL (without ESA therapy) or require transfusions to maintain this hemoglobin level, 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 patients will receive a starting dose of 0.05 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 patients, it is recommended the starting dose in subsequent patients be increased to 0.075 mg/kg. The individual dose of AF37702 Injection will be modified based on hemoglobin levels. Dose adjustments will be made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL (see Section 5.4.1). The frequency of dosing may be decreased and dosing ultimately discontinued if Hgb is maintained within the target range. Due to the lack of treatment options in this population, more frequent dosing is justified in cases of a suboptimal response. If the Investigator determines that a patient has a suboptimal response despite dose increases, the frequency of injections may be increased up to once every other week, but the total dose may not exceed 0.35 mg/kg every 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314795
|Derby, United Kingdom|
|London, United Kingdom|
|Study Director:||Medical Director||Takeda|