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NCT00504543 Clinical Trial

Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

Kidney Transplantation Clinical Trial

— AEB071  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00504543
Other study ID # CAEB071A2206
Secondary ID
Status Completed
Phase Phase 2
First received July 19, 2007
Last updated November 16, 2016
Start date July 2007
Est. completion date April 2011

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Recruitment information / eligibility
Status Completed
Enrollment 311
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AEB071
oral, twice daily
• Certican
twice daily
• Neoral
twice daily

Locations
Country Name City State
Argentina Argentina Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Australia Australia Sydney
Australia Australia Sydney
Austria Austria Innsbruck
Austria Austria Wein
Belgium Belgium Gent
Brazil Brazil Sao Paulo
Colombia Novartis Investigative Site Bogota
Colombia Novartis Investigative Site Cali
Czech Republic Czech Republic Praha
France France Lille Cedex
France France Toulouse
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Heidelberg
Italy Italy Milano
Italy Italy Milano
Netherlands Netherlands Rotterdam
Norway Norway Oslo
Singapore Novartis Investigative Site Singapore
Slovakia Novartis Investigative Site Banska Bystrica
Slovakia Novartis Investigative Site Kosice
Spain Spain Barcelona
Spain Spain Madrid
Switzerland Novartis Investigative Site Zurich
Taiwan Novartis Investigative Site Taipie

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Colombia,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Norway,  Singapore,  Slovakia,  Spain,  Switzerland,  Taiwan, 

References & Publications (1)

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 Trans — View Citation

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, 3 months after transplantation. 12 months Yes
Secondary 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 12 months Yes
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