A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.
Phase 3
Completed
- Conditions
- 1001965410038430Impaired renal function after liver transplantation
- Registration Number
- NL-OMON37144
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Allograft is functioning at an acceptable level by the time of randomization.
2. Confirmed recipient HCV status at Screening.
3. Abbreviated MDRD eGFR >= 30 mL/min/1.73m2.
4. Verification of at least one tacrolimus trough level of >= 8 ng/mL in the week prior to randomization.
Exclusion Criteria
1. Recipients of a liver from a living donor, or of a split liver.
2. History of malignancy of any organ system within the past 5 years, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC.
3. Hepatocellular carcinoma that does not fulfill Milan criteria at the time of transplantation as per explant histology of the recipient liver.
4. Women of child-bearing potential, unless they meet certain criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Renal function by the abbreviated MDRD equation<br /><br>• Treated Biopsy-Proven Acute Rejection<br /><br>• Death<br /><br>• Graft Loss</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Incidence of new-onset diabetes post-transplantation<br /><br>• Incidence of CNI-side effects<br /><br>• Progression of fibrosis in HCV positive patients<br /><br>• Recurrence rate of hepatocellular carcinoma<br /><br>• Exploratory objective: change in patterns of specific biomarkers for renal<br /><br>injury in the urine</p><br>