Contact information
Type
Scientific
Primary contact
Dr B. Hoek, van
ORCID ID
Contact details
Leiden University Medical Center
Department of Gastroenterology & Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5263507
bvhoek@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00149994
Protocol/serial number
NTR489
Study information
Scientific title
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
Acronym
DELTA
Study hypothesis
There 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
Received from local medical ethics committee
Study design
Multicentre randomised open label active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Liver transplantation
Intervention
Cyclosporin 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 type
Drug
Phase
Not Applicable
Drug names
Cyclosporin A (Neoral®), tacrolimus (Prograft®), anti-CD25 (Simulect®), prednisolone
Primary outcome measures
The incidence of biopsy-proven acute rejection (BPAR) during the first 3 months post-transplantation.
Secondary outcome measures
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 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 trial start date
25/12/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant 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 hours post-transplant
6. Able to maintain the same immunosuppressive schedule for 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124
Participant exclusion criteria
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
Recruitment start date
25/12/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Funders
Funder type
Industry
Funder name
Novartis Pharma B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00149994
Publication summary