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Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

This study is currently recruiting participants.
Verified June 2010 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Natavudh Townamchai, MD, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01758107
First received: December 25, 2012
Last updated: December 31, 2012
Last verified: June 2010
History of Changes
  Purpose

Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.


Condition Intervention Phase
Renal Transplant
 Other: Withdraw cyclosporine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute rejection rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sirolimus with Prednisolone
Sirolimus with Prednisolone, and withdraw cyclosporine
 Other: Withdraw cyclosporine
No Intervention: Sirolimus with Cyclosporine with Prednisolone

Detailed Description:

Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.

The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.

  Eligibility

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year

Exclusion Criteria:

  • history of acute rejection, or subclinical rejection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758107

Contacts
Contact: Natavudh Townamchai, MD +66894904222 ntownamchai@gmail.com

Locations
Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand
Contact: Natavudh Townamchai, MD     +66894904222     ntownamchai@gmail.com    
Principal Investigator: Natavudh Townamchai, MD            
Sponsors and Collaborators
Chulalongkorn University
  More Information

No publications provided

Responsible Party: Natavudh Townamchai, MD, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01758107     History of Changes
Other Study ID Numbers: monorapa
Study First Received: December 25, 2012
Last Updated: December 31, 2012
Health Authority: Thailand: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013