Condition category
Surgery
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.