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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:
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Chulalongkorn University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288131

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

No publications provided

Responsible Party: Kearkiat Praditpornsilpa, Associted Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01288131     History of Changes
Other Study ID Numbers: 2011/01_Medicine
Study First Received: February 1, 2011
Last Updated: January 27, 2014
Health Authority: Thailand:Institutional Review Board, Faculty of Medicine, Chulalongkorn University

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

Additional relevant MeSH terms:
Cyclophosphamide
Cyclosporine
Cyclosporins
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Alkylating Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014