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

NCT01288131 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2014-01-29

No results posted yet for this study

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.

Conditions

  • Anti-r-HuEpo Associated PRCA Subjects

Interventions

DRUG

Cyclosporine combine with mycophenolate mofetil

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

DRUG

Cyclophosphamide + pred

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

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Kearkiat Praditpornsilpa, MD · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288131 on ClinicalTrials.gov