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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Chulalongkorn University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT01288131

First received: February 1, 2011

Last updated: NA

Last verified: January 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 1, 2011

Last Updated Date

February 1, 2011

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anti-r-HuEpo Associated PRCA Subjects

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2011

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kearkiat Praditpornsilpa, MD

6622564251 ext 203

kearkiat@hotmail.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01288131

Other Study ID Numbers ^ICMJE

2011/01_Medicine

Has Data Monitoring Committee

Responsible Party

Kearkiat Praditpornsilpa.MD., Division of Nephrology, Department of Medicine, Chulalongkorn University

Study Sponsor ^ICMJE

Chulalongkorn University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kearkiat Praditpornsilpa, MD

Chulalongkorn University

Information Provided By

Chulalongkorn University

Verification Date

January 2011

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

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