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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:
ClinicalTrials.gov Identifier:
NCT01288131
First Posted: February 2, 2011
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kearkiat Praditpornsilpa, Chulalongkorn University
  Purpose
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.

Condition Intervention Phase
Anti-r-HuEpo Associated PRCA Subjects Drug: Cyclosporine combine with mycophenolate mofetil Drug: Cyclophosphamide + pred Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone

Resource links provided by NLM:


Further study details as provided by Kearkiat Praditpornsilpa, Chulalongkorn University:

Primary Outcome Measures:
  • anti-r-HuEpo antibody [ Time Frame: 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 Outcome Measures:
  • Absolute reticulocyte count [ Time Frame: 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


Enrollment: 8
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CSA+MMF
Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks
Drug: Cyclosporine combine with mycophenolate mofetil
Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
Other Names:
  • Neoral
  • Cellcept
Active Comparator: Cyclophosphamide + pred
Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day
Drug: Cyclophosphamide + pred
Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day
Other Name: Endoxan

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288131


Locations
Thailand
Kearkiat Praditpornsilpa
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Kearkiat Praditpornsilpa, MD Chulalongkorn University
  More Information

Responsible Party: Kearkiat Praditpornsilpa, Associted Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01288131     History of Changes
Other Study ID Numbers: 2011/01_Medicine
First Submitted: February 1, 2011
First Posted: February 2, 2011
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Kearkiat Praditpornsilpa, Chulalongkorn University:
Anti-r-HuEpo antibody
Anti-r-HuEpo associated PRCA
Treatment
Absolute reticulocyte count

Additional relevant MeSH terms:
Cyclophosphamide
Cyclosporins
Cyclosporine
Mycophenolic Acid
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Epoetin Alfa
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents