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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01758107
Other study ID # monorapa
Secondary ID
Status Recruiting
Phase Phase 4
First received December 25, 2012
Last updated February 1, 2015
Start date August 2010
Est. completion date October 2015

Study information

Verified date February 2015
Source Chulalongkorn University
Contact Natavudh Townamchai, MD
Phone +66894904222
Email ntownamchai@gmail.com
Is FDA regulated No
Health authority Thailand: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2015
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 85 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- history of acute rejection, or subclinical rejection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Withdraw cyclosporine


Locations

Country Name City State
Thailand Chulalongkorn University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary longterm glomerular filtration rate defined by eGFR CKD-EPI 5 years No
Secondary Acute rejection rate 5 years Yes
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