Anemia Clinical Trial
Official title:
An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease
The purpose of this study is to evaluate the ability of peginesatide (AF37702) 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).
The drug being tested in this study was peginesatide. Peginesatide injection was tested to
investigate the efficacy and safety in the treatment of anemia caused by antibody-mediated
pure red cell aplasia in participants with chronic kidney disease.
The study enrolled 22 patients. All the participants enrolled into the study received:
• Peginesatide 0.5 mg/kg subcutaneous (SC) injection
The participants received a starting dose of 0.05 mg/kg (every 4 weeks) followed by 0.1 mg/kg
dose, based on the assessment of the dose response in the initial group of 5 participants.
The frequency of each injection and the dose 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 multi-center trial was conducted in Europe. The overall time to participate in this
study was 10 years and 7 months approximately. Participants made multiple visits to the
clinic until the projected end of treatment period, which was 31-Oct-2016.
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