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

NCT01034345 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2009-12-17

No results posted yet for this study

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.

Conditions

  • Liver Transplantation

Interventions

DRUG

Sirolimus

Switch from calcineurin inhibitor maintenance immunosuppression to sirolimus treatment at the doses needed to reach trough blood levels 8-15 ng/mL.

DRUG

Calcineurin inhibitor

Patients will maintain the same immunosuppressive regimen based on calcineurin inhibitors. No modifications in the treatment will be conducted.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Alberto Sanchez Fueyo, MD · Hospital Clinic Barcelona/IDIBAPS, University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034345 on ClinicalTrials.gov