Clinical trial NCT00403416: Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kidney Transplantation
Keywords: AEB071
Tacrolimus
Mycophenolic acid
Basiliximab
Rejection
Kidney function
Immunosuppression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up
timeFrame: at 6 months
Secondary outcomes:
measure: Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)
timeFrame: at 6 months
measure: Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up
timeFrame: at 3 and 12 months
measure: Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.
timeFrame: at Month 3, 6 and 12
measure: Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms
timeFrame: from Month 3 to Month 6
measure: Safety and tolerability
timeFrame: at 3, 6 and 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Halifax
country: Canada
facility: QE II Health Sciences Center
city: Le Kremlin Bicetre
country: France
facility: Hopital Kremlin Bicetre
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Paris
country: France
facility: Hopital Necker
city: Toulouse
country: France
facility: CHU de Rangueil
city: Berlin
country: Germany
facility: Universitaetsklinik Charite
city: Berlin
country: Germany
facility: Klinikum der Humboldt Universitat Charite
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Univ. - Klinikum Heidelberg
city: Koeln
country: Germany
facility: Staedt. Krankenhaus Koeln-Merheim
city: Bologna
country: Italy
facility: Az. Osp. Di Bologna Polici. S. Orsola - Malpighi
city: Firenze
country: Italy
facility: Azienda Opedaliera Careggi - Universita degli Studi
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova - Universita degli Studi
city: Hospitalet de Llobregat
country: Spain
facility: Ciutat Santitaria I Univessitaria de Bellvitge
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Malaga
country: Spain
facility: Complejo Hospitalario Carlos Haya
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Basel
country: Switzerland
facility: Universitatsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: London
country: United Kingdom
facility: Saint George's University of London
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: