Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Chulalongkorn University.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Natavudh Townamchai, MD, Chulalongkorn University
First received: December 25, 2012
Last updated: February 1, 2015
Last verified: February 2015
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.
Other: Withdraw cyclosporine
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Primary Outcome Measures:
- longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ]
Secondary Outcome Measures:
- Acute rejection rate [ Time Frame: 5 years ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
Experimental: Sirolimus with Prednisolone
Sirolimus with Prednisolone, and withdraw cyclosporine
Other: Withdraw cyclosporine
No Intervention: Sirolimus with Cyclosporine with Prednisolone
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.
|Ages Eligible for Study:
||15 Years to 85 Years (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year
- history of acute rejection, or subclinical rejection
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01758107
|Bangkok, Thailand |
||Natavudh Townamchai, MD, MD, Chulalongkorn University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 25, 2012
||February 1, 2015
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 20, 2017
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal