Novel maintenance Immunosuppression with Controlled systemic Exposure
| ISRCTN | ISRCTN81895822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81895822 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.W. Fijter, de
Scientific
Scientific
Leiden University Medical Center
Department of Nephrology
C3-P22
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262169 |
|---|---|
| jwdefijter@lumc.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Added 26/08/09: Prospective, open label, randomised multicentre study to compare Area Under the Curve (AUC)-monitored withdrawal of either cyclosporin (Neoral®) or mycophenolate mofetil (MMF) (CellCept®) in stable renal transplant recipients on a triple regimen with cyclosporin, MMF and steroids. |
| Study acronym | NICE |
| Study objectives | To compare the safety, efficacy, and impact on non-immune toxicity of AUC-controlled withdrawal of either cyclosporine or MMF in stable renal transplant recipients currently on a triple maintenance regimen with cyclosporin, MMF and steroids. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Renal transplant |
| Intervention | Randomised, controlled, prospective multicentre study in stable renal transplant recipients, at least 6 months post-transplantation, who receive maintenance immunosuppressive treatment with cyclosporin bid, MMF 1 g bid, and steroids. In eligible patients, systemic drug exposure (cyclosporin, MMF) will be measured by a 12-hour area under the time-blood concentration curve (AUC0-12) before randomisation to one of the three study arms. Patients will be randomised 1:1:1 with stratification for the occurrence of previous acute rejection episodes. Group A will continue on their current treatment regimen aiming at C2 levels of 700 ng/ml, (range: 600-800 ng/ml). In this group AUC-values will be blinded to the clinicians and evaluated retrospectively. In group B (MMF withdrawal) cyclosporin will be dosed to reach the defined target AUC0-12 of 3250 ng.h/ml (range 3000-3500 ng.h/ml). In group C (cyclosporin withdrawal) MMF will be given at a fixed dose of 1000 mg bid at the start of the study period. After cessation of the cyclosporine AUC will be measured to adjust the dose to reach the defined MPA-AUC0-12 target of 75 mg.h/ml (range 60-90 ng.h/ml). For safety reasons the minimal dose will be 500 mg bid. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclosporin (Neoral®), mycophenolate mofetil (MMF) (CellCept®) |
| Primary outcome measure | 1. Composite of Graft function 2. Incidence of acute rejection episodes 3. Graft and patient survival |
| Secondary outcome measures | 1. Non-immune toxicity 2. Hypertension 3. Hyperlipedimia 4. Gout, uric acid 5. Magnesium 6. Nausea, dyspepsia, diarrhea 7. Anemia/Leukopenia/Thrombopenia 8. Infections (clinically defined) 9. Post-transplant lympho-proliferative disease 10. Malignancy |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Patients, 18 years or older, on maintenance therapy with cyclosporin, MMF and steroids 2. Informed consent |
| Key exclusion criteria | 1. Calculated creatinine clearance 20 ml/min 2. Multi-organ recipients 3. Patients with an (historic) PRA >60% 4. Vascular type rejection in the past 5. Patients with more than two acute rejection episodes in the past 6. Third renal transplant or more 7. Patients receiving other investigational drugs than MMF in combination with Neoral 8. Metastatic neoplasms, post-transplant lymphoproliferative disease |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/05xvt9f17 |
|---|
Funders
Funder type
Industry
Roche Nederland BV (Netherlands)
No information available
Novartis Pharma BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
