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

Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01592253

Enrollment

Registered

2012-05-07

Start date

2012-05-31

Completion date

2013-12-31

Last updated

2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Rejection of Renal Transplant

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.

Interventions

DRUGSirolimus

Beginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

Measure	Time frame	Description
biopsy proven acute rejection	Study duration is 12 months	Number of episode of biopsy proven acute rejection

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactByung Ha Chung, Assistant professor

chungbh@catholic.ac.kr82-2-2258-6066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026