Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Collaborator: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

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