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

Phase 3

Terminated

• Conditions: Anti-r-HuEpo Associated PRCA Subjects
• Interventions: Drug: Cyclosporine combine with mycophenolate mofetil; Drug: Cyclophosphamide + pred

• Registration Number: NCT01288131
• Lead Sponsor: Chulalongkorn University

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 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSA+MMF	Cyclosporine combine with mycophenolate mofetil	Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks
Cyclophosphamide + pred	Cyclophosphamide + pred	Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day

Primary Outcome Measures

Name	Time	Method
anti-r-HuEpo antibody	Day 0 and month 6	The anti-r-HuEpo antibody titer at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared

Secondary Outcome Measures

Name	Time	Method
Absolute reticulocyte count	Day 0 and month 6	The Absolute reticulocyte count at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared

Trial Locations

Locations (1)

Kearkiat Praditpornsilpa; 🇹🇭 Bangkok, Thailand