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Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

NCT01551212 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2019-05-10

Study results available
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Summary

This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.

Conditions

  • Liver Transplantation

Interventions

DRUG

Everolimus

tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg

DRUG

Tacrolimus

capsule containing 0.5, 1.0, or 5.0mg

DRUG

Corticosteroids

For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-24
Primary Completion
2017-08-08
Completion
2017-08-08

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT01551212 on ClinicalTrials.gov