Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758107

Enrollment

Registered

2013-01-01

Start date

2010-08-31

Completion date

2015-10-31

Last updated

2015-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant

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.

Interventions

OTHERWithdraw cyclosporine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
longterm glomerular filtration rate defined by eGFR CKD-EPI	5 years

Secondary

Measure	Time frame
Acute rejection rate	5 years

Countries

Thailand

Contacts

Primary ContactNatavudh Townamchai, MD

ntownamchai@gmail.com+66894904222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026