Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.
|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|
- longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Acute rejection rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||October 2015|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Sirolimus with Prednisolone
Sirolimus with Prednisolone, and withdraw cyclosporine
|Other: Withdraw cyclosporine|
|No Intervention: Sirolimus with Cyclosporine with Prednisolone|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758107
|Contact: Natavudh Townamchai, MDfirstname.lastname@example.org|
|Contact: Natavudh Townamchai, MD +66894904222 email@example.com|
|Principal Investigator: Natavudh Townamchai, MD|