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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 25, 2012
June 1, 2012
1.6 years
May 3, 2012
June 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
biopsy proven acute rejection
Number of episode of biopsy proven acute rejection
Study duration is 12 months
Secondary Outcomes (1)
Serum Creatinine, MDRD eGFR
Study duration is 12 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- Renal transplant recipient who has passed at least 10 years
- No acute rejection episode during the previous 6 months
- No change of prescription of immune suppressants
- Normal allograft function (MDRD eGFR \> 80 mL/min/1.73 m2)
- Change of allograft function less than 10 % of baseline value durant the previous 1 year
- No proteinuria and hematuria
You may not qualify if:
- Patients who donut want to participate in this study
- Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ChulWoo Yang
Seoul St. Mary's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 3, 2012
First Posted
May 7, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 25, 2012
Record last verified: 2012-06