Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Phase 4

• Conditions: Renal Transplant

• 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-12-25
• Study First Submitted QC: 2012-12-31
• Study First Posted: 2013-01-01
• Primary Completion: 2013-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-01
• Last Update Posted: 2015-02-03
• Study Completion: 2015-10

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

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