drugset / Trial / NCT01034345

Effect of Rapamycin on Tolerance-related Biomarkers on Stable Liver Transplant Recipients

NCT01034345 ↗

Phase 2 Unknown 52 enrolled Hospital Clinic of Barcelona
RandomizedParallel-groupOpen-labelTreatment

Summary

In contrast to calcineurin inhibitors, sirolimus is known to exert remarkable tolerance-promoting properties in multiple animal transplant models. Whether sirolimus is capable of enhancing tolerance-related pathways and/or promoting complete withdrawal of immunosuppressive drugs in human transplant recipients has not been previously addressed. The goal of the investigators study is to evaluate the effects of sirolimus on previously identified tolerogenic pathways in humans and, indirectly, to assess the capacity of this drug to enhance the proportion of liver recipients undergoing successful immunosuppression weaning.

Timeline

Start
2009-11
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule — —

Indications

No indication recorded.