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Novartis Everolimus Transition

NCT02096107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-08

Study results available
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Summary

Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.

Conditions

  • Graft Dysfunction
  • Interstitial Fibrosis

Interventions

DRUG

Everolimus

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

OTHER

Standard of Care

Tacrolimus, mycophenolate mofetil and steroids

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Titte Srinivas, MD · Medical University of South Carolina

  • David Taber · Medical University of South Carolina, 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
2014-02-28
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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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 NCT02096107 on ClinicalTrials.gov