Studying kidney function in patients with a liver transplant getting anti rejection therapy with Advagraf and MMF when used with or without Basiliximab

Conditions: RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT SIMULECT
MedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2008-002231-32-DE

Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

A subject is eligible for the study if all of the following apply:
1.Age = 18 years.
2.Undergoing orthotopic liver or split liver allograft transplantation.
3.Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
4.Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained).

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 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

A subject will be excluded from participation if any of the following apply:
1.Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation).
2.Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used.
3.Receiving ABO incompatible graft or a graft from a non heart beating donor.
4.Ongoing dosing with systemic corticosteroids.
5.Subjects with systemic infection requiring treatment except viral hepatitis.
6.Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
•= 3 nodules
•no node larger than 5 cm
•no metastases
•no vascular tumoral invasion
7.Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
8.Subject or donor known to be HIV positive.
9.Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, Basiliximab or mycophenolate mofetil or any of the product excipients.
10.Pregnant woman or breast-feeding mother.
11.Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
12.Unlikely to comply with the visits scheduled in the protocol.
13.Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
14.Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment.
15.Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
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Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the three therapy regimens with regard to renal function.;Secondary Objective: The secondary objective is to compare the safety and efficacy profiles of the three therapy regimens with each other.;Primary end point(s): Renal function assessed by eGFR (MDRD4 formula: estimates GFR using four variables: serum creatinine, age, race, and gender) at 24 weeks after transplantation is the primary endpoint of the study. ;Timepoint(s) of evaluation of this end point: week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Efficacy failure Rate, composite endpoint consisting of graft loss (defined as retransplantation or death) or biobsy confirmed acute rejection<br>-Renal function (assessed by Iohexol clearance, Cystatin C based formula and Cockcroft and Gault formula)<br>-Acute Rejection Episodes Incidence and Time to (both Corticosteroid sensitive and resistant)<br>-Biopsy Confirmed Acute Rejection Episodes - Incidence, Time to and Severity (both Corticosteroid sensitive and resistant)<br>-Subject and graft survival<br>-Incidence of Adverse Events<br>-Laboratory Parameters;Timepoint(s) of evaluation of this end point: up to week 24