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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403416
• Other study ID #: CAEB071A2203
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• AEB071

• Mycophenolic Acid

Locations

Country	Name	City	State
Canada	QE II Health Sciences Center	Halifax
France	Hopital Kremlin Bicetre	Le Kremlin Bicetre
France	Hopital Hotel Dieu	Nantes
France	Hopital Necker	Paris
France	CHU de Rangueil	Toulouse
Germany	Klinikum der Humboldt Universitat Charite	Berlin
Germany	Universitaetsklinik Charite	Berlin
Germany	Universitaetsklinikum Essen	Essen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Univ. - Klinikum Heidelberg	Heidelberg
Germany	Staedt. Krankenhaus Koeln-Merheim	Koeln
Italy	Az. Osp. Di Bologna Polici. S. Orsola - Malpighi	Bologna
Italy	Azienda Opedaliera Careggi - Universita degli Studi	Firenze
Italy	Azienda Ospedaliera di Padova - Universita degli Studi	Padova
Spain	Ciutat Santitaria I Univessitaria de Bellvitge	Hospitalet de Llobregat
Spain	Hospital 12 de Octubre	Madrid
Spain	Complejo Hospitalario Carlos Haya	Malaga
Spain	Hospital Doctor Peset	Valencia
Switzerland	Universitatsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Universitätsspital Zürich	Zürich
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Saint George's University of London	London
United Kingdom	Manchester Royal Infirmary	Manchester
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)		at 6 months
Secondary	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
Secondary	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
Secondary	Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms		from Month 3 to Month 6
Secondary	Safety and tolerability		at 3, 6 and 12 months

External Links

•   Results for CAEB071A2203 from the Novartis Clinical Trials website