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 |
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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
Scientific
Leiden University Medical Center
Department of Gastroenterology & Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
Phone | +31 (0)71 5263507 |
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bvhoek@lumc.nl |
Study information
Study design | Multicentre randomised open label active-controlled parallel-group trial |
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Primary study design | Interventional |
Secondary study design | Randomised parallel trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Cyclosporin A (Neoral®), tacrolimus (Prograft®), anti-CD25 (Simulect®), prednisolone |
Primary outcome measure | 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 study start date | 25/12/2002 |
Completion date | 31/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 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
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Gastroenterology - Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
https://ror.org/027bh9e22 |
Funders
Funder type
Industry
Novartis Pharma B.V. (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.