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
- Conditions
- iver transplantationSurgeryTransplanted organs and tissue status
- Registration Number
- ISRCTN83069092
- Lead Sponsor
- eiden University Medical Centre (LUMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 124
1. Patients about to undergo a primary liver transplantation
2. 18-75 years of age
3. Expected to be capable of participating 6 months post-transplantation
4. Allograft biopsies will be possible
5. Expected to be able to receive Neoral® or Prograft® within 48 hours post-transplant
6. Able to maintain the same immunosuppressive schedule for 6 months
1. Multi-organ transplant
2. Previous transplant
3. ABO incompatible transplant
4. Not eligible to receive at least 10 mg/kg as initial oral dosing of Neoral
5. Seropositive for HIV antibodies
6. Urine production less than 200 ml within 12 hours after reperfusion of the graft
7. Mycophenolate mofetil, azathioprine and/or rapamycin is prescribed post-transplantation
8. Severe coexisting disease or any unstable medical condition is present which could affect the study objectives
9. An unlicenced drug or therapy has been administered within one month prior to study entry or such therapy is to be instituted post-transplantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method