CompletedPhase 4

Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

693 participantsStarted 2003-10

Plain-language summary

The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection

Who can participate

Age range18 Years – 70 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: \- First or second transplant, cadaveric or living donor Exclusion Criteria: * Multi-organ or dual kidney transplants * Panel reactive antibodies \>50% Other protocol-defined inclusion/exclusion criteria applied

What they're measuring

Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.

Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.

Trial details

NCT IDNCT00171496

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-03

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