No registrations found.
ID
Source
Brief title
Health condition
Stable renal transplant recipients.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Composite of Graft function,
- incidence of acute rejection episodes;
2. Graft and patient survival.
Secondary outcome
Non-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.
Background summary
N/A
Study objective
To 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.
Study design
N/A
Intervention
Randomized, 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.
Department of Nephrology, C3-P22,
P.O. Box 9600
J.W. Fijter, de
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262169
jwdefijter@lumc.nl
Department of Nephrology, C3-P22,
P.O. Box 9600
J.W. Fijter, de
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262169
jwdefijter@lumc.nl
Inclusion criteria
1. Patients, 18 years or older, on maintenance therapy with Neoral, MMF and steroids;
2. Informed consent.
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 lymfoproliferative disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL440 |
| NTR-old | NTR480 |
| Other | : N/A |
| ISRCTN | ISRCTN81895822 |