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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Kearkiat Praditpornsilpa | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
Thailand,
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 |