Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Chulalongkorn University

Status and phase: Unknown; Phase 4

Conditions: Renal Transplant

Treatments: Other: Withdraw cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT01758107

monorapa

Details and patient eligibility

About

Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• history of acute rejection, or subclinical rejection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Sirolimus with Prednisolone

Experimental group

Description:

Sirolimus with Prednisolone, and withdraw cyclosporine

Treatment:

Other: Withdraw cyclosporine

Sirolimus with Cyclosporine with Prednisolone

No Intervention group