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

January 27, 2014 updated by: Kearkiat Praditpornsilpa, Chulalongkorn University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Kearkiat Praditpornsilpa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Cellcept
  • Neoral
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 Names:
  • Endoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 and month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (ESTIMATE)

February 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/01_Medicine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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