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

Anti-r-HuEpo Associated PRCA Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01288131
• Other study ID #: 2011/01_Medicine
• Status: Terminated
• Phase: Phase 3
• First received: February 1, 2011
• Last updated: January 27, 2014
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2014
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand:Institutional Review Board, Faculty of Medicine, Chulalongkorn University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anti-r-HuEpo Associated PRCA Subjects

Intervention

Drug:
• Cyclosporine combine with mycophenolate mofetil
Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
• Cyclophosphamide + pred
Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day

Locations

Country	Name	City	State
Thailand	Kearkiat Praditpornsilpa	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-r-HuEpo antibody	The anti-r-HuEpo antibody titer at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared	Day 0 and month 6	No
Secondary	Absolute reticulocyte count	The Absolute reticulocyte count at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared	Day 0 and month 6	No