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OpenTrials
Completed

NCT Number: NCT00403416

Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

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.

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Key information

Conditions

Kidney Transplantation Behavior Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

QE II Health Sciences Center, Halifax, Canada

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

AEB071

Drug

Mycophenolic Acid

Drug

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

    Time frame: at 6 months

Secondary outcomes

  1. Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)

    Time frame: at 6 months

  2. Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up

    Time frame: at 3 and 12 months

  3. Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.

    Time frame: at Month 3, 6 and 12

  4. Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms

    Time frame: from Month 3 to Month 6

  5. Safety and tolerability

    Time frame: at 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 23, 2006
Registry last updated
Dec 17, 2020

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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