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OpenTrials
Completed

NCT Number: NCT00504543

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

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

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Argentina, Buenos Aires

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEB071

Drug

oral, twice daily

Certican

Drug

twice daily

Neoral

Drug

twice daily

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Acronym: AEB071

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2007
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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