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

This study has been terminated.
(We observed >90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA)
Sponsor:
Information provided by (Responsible Party):
Kearkiat Praditpornsilpa, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01288131
First received: February 1, 2011
Last updated: January 27, 2014
Last verified: January 2014

February 1, 2011
January 27, 2014
January 2009
January 2012   (final data collection date for primary outcome measure)
anti-r-HuEpo antibody [ Time Frame: Day 0 and month 6 ] [ Designated as safety issue: No ]
The anti-r-HuEpo antibody titer at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared
Same as current
Complete list of historical versions of study NCT01288131 on ClinicalTrials.gov Archive Site
Absolute reticulocyte count [ Time Frame: Day 0 and month 6 ] [ Designated as safety issue: No ]
The Absolute reticulocyte count at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anti-r-HuEpo Associated PRCA Subjects
  • Drug: Cyclosporine combine with mycophenolate mofetil
    Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
    Other Names:
    • Neoral
    • Cellcept
  • Drug: Cyclophosphamide + pred
    Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day
    Other Name: Endoxan
  • Active Comparator: CSA+MMF
    Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks
    Intervention: Drug: Cyclosporine combine with mycophenolate mofetil
  • Active Comparator: Cyclophosphamide + pred
    Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day
    Intervention: Drug: Cyclophosphamide + pred
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01288131
2011/01_Medicine
No
Kearkiat Praditpornsilpa, Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Kearkiat Praditpornsilpa, MD Chulalongkorn University
Chulalongkorn University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP