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

Phase 1

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Mycophenolic Acid; Drug: AEB071

• Registration Number: NCT00403416
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2017-05
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolic Acid / tacrolimus	Mycophenolic Acid	-
AEB071 / tacrolimus arm 1	AEB071	-
AEB071 / tacrolimus arm 2	AEB071	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (28)

Inselspital Bern; 🇨🇭 Bern, Switzerland

Azienda Ospedaliera di Padova - Universita degli Studi; 🇮🇹 Padova, Italy

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States

Universitaetsklinik Charite; 🇩🇪 Berlin, Germany

Hopital Kremlin Bicetre; 🇫🇷 Le Kremlin Bicetre, France

Ciutat Santitaria I Univessitaria de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Spain

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

QE II Health Sciences Center; 🇨🇦 Halifax, Canada

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Hopital Hotel Dieu; 🇫🇷 Nantes, France

CHU de Rangueil; 🇫🇷 Toulouse, France

Hopital Necker; 🇫🇷 Paris, France

Klinikum der Humboldt Universitat Charite; 🇩🇪 Berlin, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Az. Osp. Di Bologna Polici. S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

Univ. - Klinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Staedt. Krankenhaus Koeln-Merheim; 🇩🇪 Koeln, Germany

Azienda Opedaliera Careggi - Universita degli Studi; 🇮🇹 Firenze, Italy

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Doctor Peset; 🇪🇸 Valencia, Spain

Universitatsspital Basel; 🇨🇭 Basel, Switzerland

Complejo Hospitalario Carlos Haya; 🇪🇸 Malaga, Spain

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland

Western Infirmary; 🇬🇧 Glasgow, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Saint George's University of London; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom