Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil [CellCept] | Drug | As prescribed; + early biopsy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with >=25% increase in fibrosis score | Day 0 to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function (creatinine clearance) | From randomization to Week 52 | |
| Incidence and time of occurrence of clinical acute rejection | From randomization to Week 52 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Besançon | 25030 | France | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| mycophenolate mofetil [CellCept] |
| Drug |
As prescribed; + standard treatment |
|
| Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes |
| Throughout study |
| Bordeaux |
| 33076 |
| France |
| Caen | 14033 | France |
| Clermont-Ferrand | 63000 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Marseille | 13385 | France |
| Nantes | 44035 | France |
| Paris | 75743 | France |
| Paris | 75908 | France |
| Poitiers | 86021 | France |
| Rouen | 76031 | France |
| Salouël | 80480 | France |
| Strasbourg | 67091 | France |
| Suresnes | 92151 | France |
| Tours | 37044 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided