Informations générales (source: ClinicalTrials.gov)
Efficacy and Safety Outcome of Two Different Targets of Advagraf® Trough Levels Between 4 Months and 12 Months After Transplantation Among de Novo Renal Transplant Recipients. (ADEQUATE)
Interventional
Phase 4
University Hospital, Tours (Voir sur ClinicalTrials)
mai 2012
mars 2015
29 juin 2024
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| GPE HOSP BROUSSAIS HEGP | Contact (sur clinicalTrials) | ||||
| IFSI DE L'HÔPITAL BICÊTRE | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Tours - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU de Angers - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU de Caen - Caen - France | Contact (sur clinicalTrials) | ||||
| Hôpital Archet II - Nice - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bois-Guillaume - 76130 - Bois-Guillaume - France | Contact (sur clinicalTrials) | ||||
| Hôpital Cavale Blanche - Brest - France | Contact (sur clinicalTrials) | ||||
| Hôpital Civil - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hôpital Dupuytren - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital Gabriel Montpied - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hôpital Maison Blanche - Reims - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pontchaillou - Rennes - France | Contact (sur clinicalTrials) | ||||
| Hôpital Sud - Amiens - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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