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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

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 (see also chapter 8.2)
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

Exclusion Criteria

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
11. Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating or who is unwilling to use effective means of contraception (see also chapter 8.2)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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