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OpenTrials
Completed

NCT Number: NCT00820911

Efficacy and Safety of AEB071 Versus Cyclosporine in de 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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, San Martín, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has been maintained on study drug for 12 months in the core study

Exclusion criteria

  • Not applicable
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

cyclosporine (reduced exposure) / everolimus

Drug

twice daily

AEB071 300 mg b.i.d. / everolimus

Drug

twice daily

AEB071 200 mg b.i.d. / everolimus

Drug

twice daily

Primary outcomes

  1. renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula

    Time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Secondary outcomes

  1. efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up

    Time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 12, 2009
Registry last updated
Feb 24, 2017

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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