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Novel maintenance Immunosuppression with Controlled systemic Exposure.


- candidate number1672
- NTR NumberNTR480
- ISRCTNISRCTN81895822
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitleNovel maintenance Immunosuppression with Controlled systemic Exposure.
- Scientific TitleProspective, open label, randomized multicenter study to compare AUC-monitored withdrawal of either cyclosporine (Neoral) or mycophenolate mofetil (MMF) in stable renal transplant recipients on a triple regimen with Neoral, MMF and steroids.
- ACRONYMNICE
- hypothesisTo compare the safety, efficacy, and impact on non-immune toxicity of AUC-controlled withdrawal of either cyclosporin (Neoral) or MMF (Cellcept) in stable renal transplant recipients currently on a triple maintenance regimen with Neoral, MMF, and steroids.
- Healt Condition(s) or Problem(s) studiedRenal transplant
- Inclusion criteria1. Patients, 18 years or older, on maintenance therapy with Neoral, MMF and steroids;
2. Informed consent.
- Exclusion criteria1. 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 lymfoproliferative disease.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate1-jan-2005
- Target number of participants100
- InterventionsRandomized, controlled, prospective multicenter study in stable renal transplant recipients, at least 6 months post-transplantation, who receive maintenance immunosuppressive treatment with cyclosporine (Neoral) b.i.d., mycophenolate mofetil (MMF) 1 gram b.i.d., and steroids.
In elegible patients, systemic drug exposure (cyclosporine, MMF) will be measured by a 12-hours area under the time-blood concentration curve (AUC0-12) before randomization to one of the three study arms.
Patients will be randomized 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) cyclosporine will be dosed to reach the defined target AUC0-12 of 3250 ng.h/ml (range 3000-3500 ng.h/ml).
- In group C (cyclosporine withdrawal) MMF will be given at a fixed dose of 1000 mg b.i.d 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 b.i.d.
- Primary outcome1. Composite of Graft function,
- incidence of acute rejection episodes;
2. Graft and patient survival.
- Secondary outcomeNon-immune toxicity
1. Hypertension;
2. Hyperlipedimia;
3. Gout, uric acid;
4. Magnesium;
5. Nausea, dyspepsia, diarrhea;
6. Anemia/Leukopenia/Thrombopenia;
7. Infections (clinically defined);
8. Post-transplant lympho-proliferative disease;
9. Malignancy.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. J.W. Fijter, de
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.W. Fijter, de
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV, Novartis Pharma B.V.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-sep-2005 - 23-jun-2008


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