NCT01288131

Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment

Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Anti-r-HuEpo Associated PRCA Subjects

Interventions

Type	Name	Description
DRUG	Cyclosporine combine with mycophenolate mofetil	Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
DRUG	Cyclophosphamide + pred	Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-02-02
• Last updated: 2014-01-29

Locations

1 site across 1 country: Thailand