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A 12-month, multi-center, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican® (1.5 mg/day starting dose) with reduced Neoral® dose ...

Update Il y a 4 ans
Reference: EUCTR2004-001052-36

A 12-month, multi-center, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican® (1.5 mg/day starting dose) with reduced Neoral® dose versus MMF with standard Neoral® dose in de novo heart transplant recipients

Woman and Man

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Extract

•To demonstrate that comparable (non-inferior) renal function (calculated creatinine clearance according to Cockroft-Gault) is achieved in cohorts of de novo heart recipients treated with Certican/reduced dose Neoral/steroids versus MMF/standard dose Neoral/steroids 6 months post transplantation.

Inclusion criteria

  • Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic cardiac transplant in combination with ciclosporin for microemulsion and corticosteroids

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