RESCUE Study (Certican? in Liver Transplant Recipients with Renal Insufficiency) A 6-month, multicenter, randomized, open-label study of safety and efficacy of Certican?-based regimen versus CNI-based regimen in maintenance liver transplant recipients - RESCUE

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

The investigator must ensure that each patient meet all the following inclusion criteria at screening visit:
•Male or female 18 - 70 years old
•Patient who has undergone a primary liver transplantation 12 to 60 months ago from a cadaveric or a living donor
•Patient with a cGFR = 60 and greater or equal than 20mL/min
•Patient receiving Prograf® with C0-h level greater than or equal to 3 and = 8 ng/mL, or Neoral® with C0-h level greater or equal to 50 and = to 150 ng/mL with or without any of the following (MPA or AZA or steroids)
•Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 6 months
•Patient in whom an allograft biopsy will not be contraindicated
•Female capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study

Are the trial subjects under 18? no
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 at screening visit will be excluded from the study participation:
•Recipient of multiple solid organ transplants
•Patient on dialysis
•Patient with an identifiable cause of renal dysfunction other than CNI toxicity
•Patient with proteinuria greater than or equal to 1.0 g/24h
•Patient with any acute rejection within 6 months prior to randomization
•Patient with platelet count of = 50,000/mm³ or white blood cell count of = 2,000/mm³ or hemoglobin value = 8 g/dL
•Patient with graft dysfunction associated with bilirubin > 34 mmol/L, or albumin < 35 g/L or prothrombin time > 1.3 INR
•HCV positive patient who needs an active anti-viral treatment
•HIV positive patient
•Patient who is breast feeding
•Patient with a current severe systemic infection
•Patient who has received an unlicensed drug or therapy within one month prior to study entry
•Presence of any hypersensitivity to drugs similar to CerticanTM(e.g. macrolides)
•Use of any other immunosuppressive drugs than Prograf®/Neoral®, steroids, azathioprine and MPA

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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