Dutch Evaluation in Liver Transplantation To Assess the efficacy of Neoral (cyclosporin A) with C-2h monitoring versus Prograft (tacrolimus) with trough monitoring in de novo liver transplant recipients.
Completed
- Conditions
- Randomized controlled open trial.Simulect (anti-CD25) and prednisolone in both arms
- Registration Number
- NL-OMON24179
- Lead Sponsor
- ovartis Pharma B.V., Arnhem, Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
1. Patients about to undergo a primary liver transplantation;
2. 18-75 years of age;
Exclusion Criteria
1. Multi-organ transplant;
2. Previous transplant;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of biopsy-proven acute rejection (BPAR) during the first 3 months post-transplantation.
- Secondary Outcome Measures
Name Time Method Efficacy, safety, tolerability of both regimens:<br /><br>1. Incidence of BPAR at 6 months;<br /><br>2. Incidence of BPAR with moderate/severe histological grading at 3 and 6 months;<br /><br>3. Patient death at 3 and 6 months;<br /><br>4. Graft loss with re-transplantation at 3 and 6 months.<br /><br>Biological liver function tests, selected lab parameters such as serum creatinin and glucose, recurrence of hepatitis C at 6 months, blood pressure values, lipid profiles, infections, occurrence of malignancies, PTDM (treated and untreated), adverse events and seriouis adverse events, pharmakokinetic endpoints related to C0 and C2h levels and their correlation to clinical 3 and 6 months outcome.