NCT01592253

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Rejection of Renal Transplant

Interventions

Type	Name	Description
DRUG	Sirolimus	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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-05-07
• Last updated: 2012-06-25

Locations

1 site across 1 country: South Korea