Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Phase 4
- Conditions
- Renal Transplant
- Interventions
- Other: Withdraw cyclosporine
- Registration Number
- NCT01758107
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year
Exclusion Criteria
- history of acute rejection, or subclinical rejection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sirolimus with Prednisolone Withdraw cyclosporine Sirolimus with Prednisolone, and withdraw cyclosporine
- Primary Outcome Measures
Name Time Method longterm glomerular filtration rate defined by eGFR CKD-EPI 5 years
- Secondary Outcome Measures
Name Time Method Acute rejection rate 5 years
Trial Locations
- Locations (1)
Chulalongkorn University
🇹🇭Bangkok, Thailand