Overview

This trial is active, not recruiting.

Condition de novo transplant disease
Treatments tacrolimus targeted half-dose, tacrolimus targeted plain dose
Phase phase 4
Sponsor University Hospital, Tours
Collaborator Astellas Pharma Inc
Start date May 2012
End date March 2015
Trial size 286 participants
Trial identifier NCT01744470, 2011-003184-29, PHAO2011/YL/ADEQUATE

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Immunosuppressive strategy with 50 % reduction of Advagraf® daily dose at M4 (randomization) and unchanged MMF dose. Targeted tacrolimus trough level are to be higher than 3 ng/mL . If the dose is not in adequation with the dispensable units, the prescribed dose will be the closest higher dose. Drug: Tacrolimus targeted half-dose
tacrolimus targeted half-dose Advagraf®
(Experimental)
Immunosuppressive strategy will remain identical after randomization (M4): unchanged Advagraf® and MMF doses. Targeted tacrolimus trough level are to be between 7 and 12 ng/mL Drug: Tacrolimus targeted plain dose
tacrolimus targeted plain dose Advagraf®

Primary Outcomes

Measure
Renal function at one year post transplantation
time frame: 12 months

Secondary Outcomes

Measure
To determine and compare according to randomized group
time frame: 12 months
To determine and compare according to randomized group
time frame: 12 months
To determine and compare according to randomized group
time frame: 12 months
To determine and compare according to randomized group
time frame: 12 months
To determine and compare according to randomized group
time frame: 12 months
To determine and compare according to randomized group
time frame: 12 months
To determine and compare according to randomized group
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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.
Principal investigator Yvon LEBRANCHU
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University Hospital, Tours.