Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient

Seoul St. Mary's Hospital

Status: Unknown

Conditions: Acute Rejection of Renal Transplant

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01592253

RAPA CONVERT TRIAL

Details and patient eligibility

About

For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Renal transplant recipient who has passed at least 10 years
2. No acute rejection episode during the previous 6 months
3. No change of prescription of immune suppressants
4. Normal allograft function (MDRD eGFR > 80 mL/min/1.73 m2)
5. Change of allograft function less than 10 % of baseline value durant the previous 1 year
6. No proteinuria and hematuria

Exclusion criteria

1. Patients who donut want to participate in this study
2. Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)