CompletedPhase 1/2

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

United States, Canada, France215 participantsStarted 2006-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up

Timeframe: at 6 months

Trial details

NCT IDNCT00403416

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05

View on ClinicalTrials.gov More Kidney Transplantation trials