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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288131

Enrollment

Registered

2011-02-02

Start date

2009-01-31

Completion date

2012-01-31

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-r-HuEpo Associated PRCA Subjects

Keywords

Anti-r-HuEpo antibody, Anti-r-HuEpo associated PRCA, Treatment, Absolute reticulocyte count

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.

Interventions

DRUGCyclosporine combine with mycophenolate mofetil

Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks

DRUGCyclophosphamide + pred

Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026