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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anti-r-HuEpo Associated PRCA Subjects

Intervention / Treatment
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* Drug: Cyclosporine combine with mycophenolate mofetil
* Drug: Cyclophosphamide + pred


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSA+MMF<br>Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks | Drug: Cyclosporine combine with mycophenolate mofetil<br>* Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks<br>* Other names: Cellcept;|
| Active Comparator: Cyclophosphamide + pred<br>Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day | Drug: Cyclophosphamide + pred<br>* Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day<br>* Other names: Endoxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-r-HuEpo antibody, Anti-r-HuEpo associated PRCA, Treatment, Absolute reticulocyte count