PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT Study A twelve-month, multicenter, randomized, open-label study of safety, tolerability and efficacy of Cer...

Update Il y a 4 ans
Reference: EUCTR2005-002920-32

PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT Study A twelve-month, multicenter, randomized, open-label study of safety, tolerability and efficacy of Certican-based regimen versus calcineurin inhibitor-based regimen in de novo liver transplant recipients

Woman and Man

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Extract

The primary objective is to show superiority of Certican®-based regimen with discontinuation of initial CNI therapy in renal function as compared to continuation of CNI based treatment at 11 months post randomization in liver transplant patients. This will be evaluated by comparing renal function calculated by glomerular filtration rate (cGFR) (Cockcroft-Gault formula) between the two groups of patients.


Inclusion criteria

  • prophylaxis of organ rejections in adult patients after liver transplantation