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CNI-free "Bottom"-up Immunosuppression in Patients Undergoing Liver Transplantation

NCT01023542 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-07-01

No results posted yet for this study

Summary

The primary objective of the trial is to evaluate efficacy and safety of delayed introduction (up to 30 days post-transplantation in patients without signs of acute rejection that had received an aIL-2 induction and MMF) of either cyclosporine or everolimus versus a 5-day delay of cyclosporine in combination with MMF.

Conditions

  • Renal Impairment
  • Liver Transplantation
  • Everolimus

Interventions

DRUG

delayed, low-dose CNI

immunosuppression

DRUG

BU-CNI

Immunosuppression

DRUG

BU-Everolimus

Immunosuppression

Sponsors & Collaborators

Principal Investigators

  • Andreas A Schnitzbauer, MD · Regensburg University Hospital, Department of Surgery

  • Hans J Schlitt, MD · Regensburg University Hospital Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT01023542 on ClinicalTrials.gov