Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 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: February 1, 2015
Last verified: February 2015

December 25, 2012
February 1, 2015
August 2010
August 2013   (final data collection date for primary outcome measure)
longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01758107 on ClinicalTrials.gov Archive Site
Acute rejection rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplant
Other: Withdraw cyclosporine
  • Experimental: Sirolimus with Prednisolone
    Sirolimus with Prednisolone, and withdraw cyclosporine
    Intervention: Other: Withdraw cyclosporine
  • No Intervention: Sirolimus with Cyclosporine with Prednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2015
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • history of acute rejection, or subclinical rejection
Both
15 Years to 85 Years   (Child, Adult, Senior)
No
Contact: Natavudh Townamchai, MD +66894904222 ntownamchai@gmail.com
Thailand
 
NCT01758107
monorapa
Yes
Not Provided
Not Provided
Natavudh Townamchai, MD, Chulalongkorn University
Chulalongkorn University
Not Provided
Not Provided
Chulalongkorn University
February 2015

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