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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24179
Enrollment
124
Registered
2005-09-16
Start date
2002-12-25
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Randomized controlled open trial. Simulect (anti-CD25) and prednisolone in both arms

Interventions

Neoral (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

Sponsors

Novartis Pharma B.V., Arnhem, Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 h post-transplant; 6. Able to maintain the same immunosuppressive schedule for 6 months.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
The incidence of biopsy-proven acute rejection (BPAR) during the first 3 months post-transplantation.—

Secondary

MeasureTime frame
Efficacy, 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.—

Contacts

Public ContactB. Hoek, van

Leiden University Medical Center (LUMC) Department of Gastroenterology and Hepatology C4P room 13 P.O. Box 9600

b.van_hoek@lumc.nl+31 (0)71 5263507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)