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

Not Applicable

• Conditions: Acute Rejection of Renal Transplant

• Registration Number: NCT01592253
• Lead Sponsor: Seoul St. Mary's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
biopsy proven acute rejection	Study duration is 12 months	Number of episode of biopsy proven acute rejection

Secondary Outcome Measures

Name	Time	Method
Serum Creatinine, MDRD eGFR	Study duration is 12 months	Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline