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 (NCT)	NCT00149994
Protocol serial number	NTR489
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	Novartis Pharma B.V. (Netherlands)

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

Primary study design	Interventional
Study design	Multicentre randomised open label active-controlled parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
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
Study acronym	DELTA
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cyclosporin A (Neoral®), tacrolimus (Prograft®), anti-CD25 (Simulect®), prednisolone
Primary outcome measure(s)	The incidence of biopsy-proven acute rejection (BPAR) during the first 3 months post-transplantation.
Key secondary outcome measure(s)	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.
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	124
Key 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
Key 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
Date of first enrolment	25/12/2002
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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