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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00403416
First received: November 22, 2006
Last updated: February 26, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: AEB071
Drug: Mycophenolic Acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms [ Time Frame: from Month 3 to Month 6 ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: October 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mycophenolic Acid / tacrolimus Drug: Mycophenolic Acid
Experimental: AEB071 / tacrolimus arm 1 Drug: AEB071
Experimental: AEB071 / tacrolimus arm 2 Drug: AEB071

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403416

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00403416     History of Changes
Other Study ID Numbers: CAEB071A2203
Study First Received: November 22, 2006
Last Updated: February 26, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Switzerland: Swissmedic

Keywords provided by Novartis:
AEB071
Tacrolimus
Mycophenolic acid
Basiliximab
Rejection
Kidney function
Immunosuppression

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014