ovel maintenance Immunosuppressionwith Controlled systemic Exposure.
Completed
- Conditions
- Stable renal transplant recipients.
- Registration Number
- NL-OMON27195
- Lead Sponsor
- Roche, Novartis
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Composite of Graft function, <br />- incidence of acute rejection episodes; <br /><br>2. Graft and patient survival.
- Secondary Outcome Measures
Name Time Method on-immune toxicity<br /><br>1. Hypertension;<Br><br>2. Hyperlipedimia;<br /><br>3. Gout, uric acid;<br /><br>4. Magnesium;<br /><br>5. Nausea, dyspepsia, diarrhea;<br /><br>6. Anemia/Leukopenia/Thrombopenia;<br /><br>7. Infections (clinically defined);<br /><br>8. Post-transplant lympho-proliferative disease;<br /><br>9. Malignancy.