Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients. (Prometheus)

July 13, 2018 updated by: Novartis Pharmaceuticals

A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)

A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients willing and capable of providing written informed consent for study participation.
  • Adults 18 to 70 years of age.
  • Liver allograft from a deceased or living donor.
  • Treated with a CNI containing immunosuppressive regimen.
  • Liver transplant 6 to 24 months prior to screening.
  • Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function.
  • Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

Exclusion Criteria:

  • Multiple solid organ transplant recipients
  • Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
  • Malignant diseases other than neoplasms of the skin.
  • Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
  • Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
  • HIV positivity

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Everolimus with MMF (TAC-withdrawal)
Everolimus (RAD001) with MMF and Steroids
Drug: TAC withdrawal
Everolimus (RAD001) with MMF and Steroids
Active Comparator: Everolimus with reduced TAC
Everolimus (RAD001) with reduced TAC and Steroids
Drug: Everolimus with reduced TAC
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function
Time Frame: Randomization to Month 6
The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.
Randomization to Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (tBPAR, graft loss, death, loss to follow-up)
Time Frame: To Month 6
Composite efficacy failure of tBPAR, graft loss, death or loss to follow-up and each of its components at month 6 will be analysed per event rate estimates, Kaplan-Meier and regression models. The time to the first occurrence of the event will be calculated from the randomization date.
To Month 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: at 24 months (end of study)
Routine safety will be assessed via AE reporting, vital signs, and laboratory data.
at 24 months (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001HDE53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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