De Novo Transplant Disease
Conditions
Keywords
Renal, Transplantation, Tacrolimus
Brief summary
This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).
Interventions
Sponsors
Astellas Pharma Inc
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 et 70 years * Patient accepting to give a written informed consent * Recipients of a first renal allograft * Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type. * Absence of positive DSA using Luminex®, MFI\>1,000 * Negative cross-match in cytotoxicity * Patient without difficulty to understand and communicate with the investigator and his collaborators * Patient entitled to Health System benefits or other such benefits.
Exclusion criteria
* Multiple organ transplantation * Recipients of a dual kidney transplant * Previous renal allograft * History of any other transplantation * Receiving a graft from a non-heart-beating donor * Patient BMI \> 35 * Patients with evidence of severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin \> 3 times upper limit of normal) at screening. * Significant severe infection, active peptic ulcer and/or difficulty to absorb oral drugs (active upper gastro-intestinal tract malabsorption syndrome) * HIV-positive patients, or with an active B or C hepatitis * Patients with de novo malignancy prior to transplantation, other than efficiently treated basal or squamous cell carcinoma of the skin. * Leucocyte count lower than 2500/mm3 * Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control. * Known allergy or intolerance to basiliximab, tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients * Participation in a clinical trial or expanded access trial with an investigational drug within 4 weeks prior to enrollment or concomitantly with this study * Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function at one year post transplantation | 12 months | Renal function at one year post transplantation estimated by the glomerular filtration rate (GFR) using MDRD 4 (Modification Diet in Renal Disease). Crude difference in renal function at one year between groups and the change of renal function between 4 months and one year in each group will be analyzed and compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine and compare according to randomized group | 12 months | Routine graft histology at M12 assessed using Banff 2009 classification, with specific analysis of interstitial fibrosis (IF) using numeric quantification |
Countries
France
Outcome results
None listed