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

Chulalongkorn University

Status and phase: Terminated; Phase 3

Conditions: Anti-r-HuEpo Associated PRCA Subjects

Treatments: Drug: Cyclosporine combine with mycophenolate mofetil; Drug: Cyclophosphamide + pred

Study type: Interventional

Funder types: Other

Identifiers

NCT01288131

2011/01_Medicine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 18 years old
• CKD patient with anti-r-huEpo associated PRCA

Exclusion criteria

• Pregnancy or lactating women
• Receiving immunosuppression
• Active infection
• Previous history of allergic reaction to cyclosporine, mycophenolate mofetil, cyclophosphamide, prednisolone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

CSA+MMF

Active Comparator group

Description:

Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks

Treatment:

Drug: Cyclosporine combine with mycophenolate mofetil

Cyclophosphamide + pred

Active Comparator group

Description:

Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day

Treatment:

Drug: Cyclophosphamide + pred