PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT StudyA 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 - PROTECT

ovartis Pharma GmbH0 个研究点目标入组 200 人开始时间: 2005年12月22日最近更新: 2013年5月27日

研究概览

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•The investigator must ensure that each patient meet all the following inclusion criteria at study entry:
•1. Males or females 18 - 70 years old
•2. Liver transplant recipient (living or deceased donor)
•3. Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
•4. Patients in whom an allograft biopsy will not be contraindicated
•5. Females capable of becoming pregnant must have a negative pregnancy test prior to start of study and are required to practice a medically approved method of birth control for the duration of the study
•6. Patients with cGFR > 50 ml/min
•Are the trial subjects under 18?
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•The patient meeting any of the following criteria will be excluded from the study participation:
•1. Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
•2. HCV positive patients who need an active anti-viral treatment (HCV-positive patients without active antiviral treatment are allowed)
•3. HIV positive patients
•4. Patients who are breast feeding
•5. Patients with a current severe systemic infection
•6. Patients who have received an unlicensed drug or therapy within one month prior to study entry
•7. Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
•8. Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
•9. Patients that have received Simulect prior to this study.
•10. Patients that have received any immunosuppressive regimen 2 months prior to this study.

发起方

ovartis Pharma GmbH