Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
|ClinicalTrials.gov Identifier: NCT01758107|
Recruitment Status : Unknown
Verified February 2015 by Natavudh Townamchai, MD, Chulalongkorn University.
Recruitment status was: Recruiting
First Posted : January 1, 2013
Last Update Posted : February 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Other: Withdraw cyclosporine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||October 2015|
Experimental: Sirolimus with Prednisolone
Sirolimus with Prednisolone, and withdraw cyclosporine
Other: Withdraw cyclosporine
|No Intervention: Sirolimus with Cyclosporine with Prednisolone|
- longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ]
- Acute rejection rate [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758107
|Contact: Natavudh Townamchai, MDemail@example.com|
|Contact: Natavudh Townamchai, MD +66894904222 firstname.lastname@example.org|
|Principal Investigator: Natavudh Townamchai, MD|