A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation
- Registration Number
- NCT00817687
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- adult patients, >=18 years of age;
- in receipt of an initial cadaveric kidney transplant;
- in receipt of graft with biopsy;
- in receipt of a 'marginal' kidney transplant.
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Exclusion Criteria
- in receipt of a second kidney transplant;
- in receipt of a multi-organ transplant or a double kidney transplant;
- malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
- replicating hepatitis B and/or C, or HIV positive serology.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mycophenolate mofetil [CellCept] - 2 mycophenolate mofetil [CellCept] -
- Primary Outcome Measures
Name Time Method Proportion of patients with >=25% increase in fibrosis score Day 0 to Week 52
- Secondary Outcome Measures
Name Time Method Renal function (creatinine clearance) From randomization to Week 52 Incidence and time of occurrence of clinical acute rejection From randomization to Week 52 Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes Throughout study