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

ISRCTN ISRCTN83069092
DOI https://doi.org/10.1186/ISRCTN83069092
ClinicalTrials.gov number NCT00149994
Secondary identifying numbers NTR489
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
15/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B. Hoek, van
Scientific

Leiden University Medical Center
Department of Gastroenterology & Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 5263507
Email bvhoek@lumc.nl

Study information

Study designMulticentre randomised open label active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronymDELTA
Study objectivesThere is a difference in rate of biopsy-proven acute rejection between a Neoral® regimen with C2 monitoring versus a Tacrolimus regimen with C0 monitoring.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedLiver transplantation
InterventionCyclosporin A with C-2h monitoring versus tacrolimus with trough monitoring in de novo liver transplant recipients (randomised controlled open trial) with anti-CD25 and prednisolone in both arms.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Cyclosporin A (Neoral®), tacrolimus (Prograft®), anti-CD25 (Simulect®), prednisolone
Primary outcome measureThe incidence of biopsy-proven acute rejection (BPAR) during the first 3 months post-transplantation.
Secondary outcome measuresEfficacy, 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 creatinine and glucose, recurrence of hepatitis C at 6 months, blood pressure values, lipid profiles, infections, occurrence of malignancies, Post-Transplant Diabetes Mellitus (PTDM) (treated and untreated), adverse events and serious adverse events, pharmakokinetic endpoints related to C0 and C2h levels and their correlation to clinical 3 and 6 months outcome.
Overall study start date25/12/2002
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants124
Key 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 hours post-transplant
6. Able to maintain the same immunosuppressive schedule for 6 months
Key exclusion criteria1. 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
Date of first enrolment25/12/2002
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
Hospital/treatment centre

Department of Gastroenterology - Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Industry

Novartis Pharma B.V. (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results No No

Editorial Notes

15/04/2019: No publications found. Verifying results with principal investigator
21/03/2016: added link to results - basic reporting.