NCT01758107

Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 15 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplant

Interventions

Type	Name	Description
OTHER	Withdraw cyclosporine

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-08-01
• Completion: 2015-10-01
• First posted: 2013-01-01
• Last updated: 2015-02-03

Locations

1 site across 1 country: Thailand