Clinical trial NCT00504543: Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
Official title: A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: Kidney transplant, AEB071
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 311
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 assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.


Eligibility criteria: Inclusion criteria

* Male and female patients 18 years or older
* Recipients of first kidney transplant from a deceased or living not related donor

Exclusion criteria

* Need for medication prohibited in the study
* Patients with heart disease (own or family history)
* Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
* Patients with high immunological risks
* Patients with a history of cancer
* 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, 3 months after transplantation.
timeFrame: 12 months
Secondary outcomes:
measure: Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK
timeFrame: 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Argentina
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Sydney
country: Australia
facility: Australia
city: Sydney
country: Australia
facility: Australia
city: Innsbruck
country: Austria
facility: Austria
city: Wein
country: Austria
facility: Austria
city: Gent
country: Belgium
facility: Belgium
city: Sao Paulo
country: Brazil
facility: Brazil
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigative Site
city: Praha
country: Czech Republic
facility: Czech Republic
city: Lille Cedex
country: France
facility: France
city: Toulouse
country: France
facility: France
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Italy
city: Milano
country: Italy
facility: Italy
city: Rotterdam
country: Netherlands
facility: Netherlands
city: Oslo
country: Norway
facility: Norway
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Spain
city: Madrid
country: Spain
facility: Spain
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Taipie
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.