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

Seoul St. Mary's Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Acute Rejection of Renal Transplant

Interventions

SirolimusDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

biopsy proven acute rejection

Number of episode of biopsy proven acute rejection

Time frame: Study duration is 12 months

Secondary Outcomes

Serum Creatinine, MDRD eGFR

Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline