Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

December 11, 2020 updated by: Novartis Pharmaceuticals

12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Halifax, Canada, B3H 1V7
        • QE II Health Sciences Center
  • France
      • Le Kremlin Bicetre, France, 94270
        • Hôpital Kremlin Bicêtre
      • Nantes, France, 44035
        • Hopital Hotel Dieu
      • Paris, France, 75015
        • Hopital Necker
      • Toulouse, France, 31403
        • CHU de Rangueil
  • Germany
      • Berlin, Germany, 10117
        • Universitaetsklinik Charite
      • Berlin, Germany, 13353
        • Klinikum der Humboldt Universitat Charite
      • Essen, Germany, 45122
        • Universitaetsklinikum Essen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Univ. - Klinikum Heidelberg
      • Koeln, Germany, 51109
        • Staedt. Krankenhaus Koeln-Merheim
  • Italy
      • Bologna, Italy, 40138
        • Az. Osp. Di Bologna Polici. S. Orsola - Malpighi
      • Firenze, Italy, 50134
        • Azienda Opedaliera Careggi - Universita degli Studi
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova - Universita degli Studi
  • Spain
      • Hospitalet de Llobregat, Spain, 08907
        • Ciutat Santitaria I Univessitaria de Bellvitge
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Malaga, Spain, 28041
        • Complejo Hospitalario Carlos Haya
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Zürich, Switzerland, 8091
        • Universitätsspital Zürich
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Glasgow, United Kingdom, G11 6NT
        • Western Infirmary
      • London, United Kingdom
        • Saint George's University of London
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
  • United States
    • California
      • San Francisco, California, United States, 94143-0780
        • University of California, San Francisco
    • Ohio
      • Cleveland, Ohio, United States, 44106-5048
        • University Hospitals of Cleveland
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-7375
        • University of Wisconsin Hospital and Clinics

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

  • Male and female patients of any race 18 years or older
  • Adult recipients of a kidney transplant from a deceased or from a living donor
  • Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.

Exclusion criteria

  • Need for medication prohibited by the protocol
  • Patients or donors infected with hepatitis B or C, or with HIV.
  • Patients with a history of cancer
  • Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.

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
Active Comparator: Mycophenolic Acid / tacrolimus
Drug: Mycophenolic Acid
Experimental: AEB071 / tacrolimus arm 1
Drug: AEB071
Experimental: AEB071 / tacrolimus arm 2
Drug: AEB071

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)
Time Frame: at 6 months
at 6 months
Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up
Time Frame: at 3 and 12 months
at 3 and 12 months
Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.
Time Frame: at Month 3, 6 and 12
at Month 3, 6 and 12
Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms
Time Frame: from Month 3 to Month 6
from Month 3 to Month 6
Safety and tolerability
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

October 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEB071A2203

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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