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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.


- candidate number1699
- NTR NumberNTR489
- ISRCTNISRCTN83069092
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR16-sep-2005
- Secondary IDsN/A 
- Public TitleDutch 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.
- Scientific TitleDutch 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.
- ACRONYMDELTA Study
- hypothesisThere is a difference in rate of biopsy-proven acute rejection between a Neoral regimen with C2 monitoring versus a Tacrolimus regimen with C0 monitoring.
- Healt Condition(s) or Problem(s) studiedLiver transplantation
- Inclusion criteria1. 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 h post-transplant;
6. Able to maintain the same immunosuppressive schedule for 6 months.
- Exclusion criteria1. Multi-organ transplant;
2. Previous transplant;
3. ABO incompatible transplant;
4. Not elegible to receive at least 10 mg/kg as initial oral dosing of Neoral;
5. Seropositive for HIV antribodies;
6. Urine production less than 200 ml within 12 hours after reperfusion of the graft;
7. If mycophenolate mofetil;
8. Azathioprine and/or rapamycin is prescribed post-transplantation;
9. Severe coexisting disease or if any unstable medical condition is present which could affect the study objectives;
10. If an unlicenced drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 25-dec-2002
- planned closingdate31-dec-2006
- Target number of participants124
- InterventionsNeoral (cyclosporin A) with C-2h monitoring versus Prograft (tacrolimus) with trough monitoring in de novo liver transplant recipients (randomized controlled open trial) with Simulect (anti-CD25) and prednisolone in both arms.
- Primary outcomeThe incidence of biopsy-proven acute rejection (BPAR) during the first 3 months post-transplantation.
- Secondary outcomeEfficacy, safety, tolerability of both regimens:
1. Incidence of BPAR at 6 months;
2. Incidence of BPAR with moderate/severe histological grading at 3 and 6 months;
3. Patient death at 3 and 6 months;
4. Graft loss with re-transplantation at 3 and 6 months.
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.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. B. Hoek, van
- CONTACT for SCIENTIFIC QUERIESDr. A.P. Berg, van den
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Novartis Pharma B.V.
- PublicationsN/A
- Brief summaryNeoral (cyclosporin A) with C-2h monitoring versus Prograft (tacrolimus) with trough monitoring in de novo liver transplant recipients (randomized controlled open trial) with Simulect (anti-CD25) and prednisolone in both arms, to compare the incidence of biopsy-proven acute rejection, safety, efficacy and tolerability.
- Main changes (audit trail)
- RECORD17-sep-2005 - 2-sep-2009


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