Study to evaluate the renal function of adult liver transplant recipients treated with two everolimus-based immunosuppressive regimens (tacrolimus withdrawal vs. minimization) until 12 monthspost-transplant, with a 6-months follow-up.

Phase 1

Active, not recruiting

• Conditions: liver transplant; MedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-004325-91-IT
• Lead Sponsor: OVARTIS FARMA S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-29
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria at Baseline (Visit 1)
• Male and female liver transplant recipients who are = 18 years of age, treated with a tacrolimus-based immunosuppressive regimen, who have received an induction therapy or i.v. steroids as per local clinical practice.
• Recipients of a full-size or technically modified liver allograft will be eligible at 4 weeks (± 7 days) after liver transplantation.
• Allograft is functioning at an acceptable level by the time of Baseline as defined by the AST, ALT, total bilirubin levels = 3 times ULN and INR < 1.5 times ULN.
• Abbreviated MDRD-4 eGFR = 30 mL/min/1.73m2. Serum creatinine results obtained within 5 days prior to Baseline are acceptable.

Inclusion criteria at Randomization (Visit 5)
• Effective tacrolimus minimization, confirmed by stable blood trough levels in the two months prior to randomization, i.e. verification of last two tacrolimus blood trough level = 5 ng/mL in the two months prior to randomization. Investigators should make adjustments in tacrolimus dosing to continue to target trough levels = 5 ng/mL prior to randomization.
• Abbreviated MDRD-4 eGFR = 30 mL/min/1.73m2. Serum creatinine results obtained within 5 days prior to Visit 5 are acceptable.
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 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Exclusion criteria at Baseline (Visit 1)
• Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an AB0 incompatible transplant.
• Patients who experienced more than one episode of treated biopsy proven acute rejection (BANFF = 3 or RAI = 7) or one steroid-resistant acute rejection.
• Patients who require renal replacement therapy.
• Patients with a confirmed spot urine protein/creatinine ratio that indicates =1.0 g/24 hrs of proteinuria.
• History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC.

Exclusion criteria at Randomization (Visit 5)
• Patients who experienced more than two episodes of treated biopsy proven acute rejection (BANFF = 3 or RAI = 7) since transplantation or one steroid-resistant acute rejection during the run-in period.
• Patients with a confirmed spot urine protein/creatinine ratio that indicates = 3.0 g/24 hrs of proteinuria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified