Clinical Trial: Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone
Brief Summary: Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia in this study.
Detailed Summary: Recombinant human erythropoietin was the first biotherapeutic medicinal product derived from recombinant DNA technology for the treatment of anemia in patients with chronic kidney disease (CKD). Although r-HuEpo raises hemoglobin levels in CKD and improves morbidity associated with anemia in CKD patients, the adverse immunological effect of r-HuEpo administered subcutaneously can result in anti-r-HuEpo associated PRCA. We aim to evaluate the effectiveness of two treatment protocol, cyclosporine combined with mycophenolate mofetil and cyclophosphamide combined with prednisolone for treatment of anti-r-HuEpo associated PRCA.
Sponsor: Chulalongkorn University
Current Primary Outcome: anti-r-HuEpo antibody [ Time Frame: Day 0 and month 6 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Absolute reticulocyte count [ Time Frame: Day 0 and month 6 ]
Original Secondary Outcome: Same as current
Information By: Chulalongkorn University
Dates:
Date Received: February 1, 2011
Date Started: January 2009
Date Completion:
Last Updated: January 27, 2014
Last Verified: January 2014
