Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

December 15, 2020 updated by: Novartis Pharmaceuticals

A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Bruxelles, Belgium
        • CHU Erasme
      • Leuven, Belgium
        • UZ Gasthuisberg
  • Canada
      • Halifax, Canada
        • Queen Elizabeth II
      • Montreal Quebec, Canada
        • Hopital Maisonneuve-Rosemont
    • Ontario
      • Hamilton, Ontario, Canada
        • Saint Joseph's Hospital
  • Germany
      • Berlin, Germany
        • Klinikum der Humboldt Universitat Charite
      • Berlin, Germany
        • Universitaetsklinik Charite
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Univ.-Klinikum Heidelberg
      • Koeln, Germany
        • Staedt. Kliniken Koeln-Merheim
      • Regensburg, Germany
        • Klinikum der Universitaet Regensburg
  • Spain
      • Barcelona, Spain
        • Fundación Puigvert
      • La Coruna, Spain
        • Hospital Juan Canalejo
  • Sweden
      • Goteborg, Sweden
        • Enheten f Transpl och Leverkir, SU/Sahlgrenska
      • Uppsala, Sweden
        • Transplantationskirurgiska mottagningen, Akademiska Sjukhuse
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • Leicester, United Kingdom
        • Leicester General Hospital
      • Oxford, United Kingdom
        • Churchill Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Medical Center
      • San Diego, California, United States, 92103-8401
        • University of California San Diego
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94143
        • UCSF
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Science Center
    • Florida
      • Tampa, Florida, United States
        • Lifelink, Inc.
    • Maryland
      • Baltimore, Maryland, United States
        • U of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Health System
      • Detroit, Michigan, United States
        • Henry Ford Hospital Transplant Institute
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States
        • Comprehensive Transplant Clinic
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati, Dept of Internal Medicine
      • Toledo, Ohio, United States
        • University of Toledo Health Science Campus
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System-Presbyterian Medical Center
    • Texas
      • Dallas, Texas, United States
        • Baylor U Medical Center
      • Galveston, Texas, United States, 77555 - 0561
        • University of Texas Medical Branch at Galveston
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah
    • Wisconsin
      • Madison, Wisconsin, United States
        • U of Wisconsin Hospital Clinics
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Male and female patients of any race 18 years or older
  • Adult recipients of kidney transplant from a deceased or living donor
  • Recipients of a functioning kidney within 24 hours post transplant

Exclusion:

  • Need for medication prohibited by the protocol
  • Patients or donors infected with Hepatitis B,C or HIV
  • Patients with a history of cancer within last 5 years
  • Patients with history of significant cardiac disorder
  • Patients of high-risk immunological status

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAEB071A2207

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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