Overview

This trial is active, not recruiting.

Condition renal transplant
Treatments absence of corticotherapy post-transplantation, corticotherapy post-transplantation
Phase phase 4
Sponsor Nantes University Hospital
Start date April 2012
End date October 2016
Trial size 193 participants
Trial identifier NCT01541176, RC11_0013

Summary

The main objective of this study is to demonstrate that the absence of post-transplantation corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy that includes standard oral corticosteroids.The secondary objectives of the study consist to compare on various parameters (fibrosis progression, renal function, dialysis, ratio of proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical and biological tolerance) therapy with no corticosteroids post-transplantation in comparison to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary objectives of the study consist also to compare the two techniques for assessing fibrosis by numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical pathologists).

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)
All patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) without corticotherapy post-transplantation.
absence of corticotherapy post-transplantation
No study treatment
(Active Comparator)
All patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) with corticotherapy post-transplantation : prednisone or prednisolone orally for at least one year post-transplantation.
corticotherapy post-transplantation
Prednisone or prednisolone orally for at least one year post-transplantation with the following minimal doses : D1 to D14 : 20 mg/day, D15 to M1 : 15 mg/day, M1 to M3 : 10 mg/day, M3 to M12 : 5 mg/day.

Primary Outcomes

Measure
Percentage of fibrosis of the graft
time frame: One year post-transplantation

Secondary Outcomes

Measure
Percentage of fibrosis of the graft
time frame: One year post-transplantation
Percentage of fibrosis of the graft.
time frame: One year post-transplantation
Average glomerular filtration rate
time frame: One year post-transplantation
Dialysis session
time frame: One year post-transplantation
Ratio of proteinuria/creatinuria
time frame: One year post-transplantation
Episode of acute rejection
time frame: One year post-transplantation
Diagnosis of DSA
time frame: One year post-transplantation
Percentage of graft failure
time frame: One year post-transplantation
Difference between numerical reading of fibrosis and evaluation by anatomical pathologists
time frame: One year post-transplantation
Number of adverse events
time frame: One year post-transplantation

Eligibility Criteria

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

Pre-Inclusion Criteria: - Adults aged 18 to70 years, - Accepting to give, after information, their signed informed consent form, - Not having difficulties to understand and communicate with the investigator and his representatives, - Requiring a renal transplant [first or second transplant (except if the first renal transplant was lost due to rejection)], - Patient insured. Inclusion criteria : - Transplant of a kidney from a deceased or living donor (non HLA-identical) with ABO compatibility, - Existence of a renal graft biopsy (or of one of the grafts, if bi-renal transplant) before transplantation, - Percentage of positive responses to PRA (panel reactive antibodies), measured by the Luminex® less than 20% of IgG anti-T or absence of positive DSA by Luminex regardless of the mean fluorescence (MFI) within the last 6 months, - Negative cross match T in cytotoxicity and / or flow cytometry, - Negative pregnancy test for patients of childbearing age, and consent to use an effective contraception throughout the study and 6 weeks after the end of the study. Exclusion Criteria: - First renal transplant lost due to rejection, - Combined transplantation, - Previous history of transplantation other than kidney, - Non beating donor heart, - Presence of positive DSA by Luminex® regardless of the average of fluorescence (MFI), - Patients receiving corticosteroids at the time of transplantation, - Necessity to continue administration of systemic immunosuppressive treatment before transplantation, - Infections or severe diarrhea, vomiting, upper gastrointestinal tract malabsorption or active peptic ulcers, concomitant, significant and uncontrolled, - Subject or HIV positive donor, - Replicating viral hepatitis at the time of randomization, - Known allergy or intolerance to tacrolimus, macrolide, corticosteroids, mycophenolate mofetil or to any of the excipients, - Diagnosis of de novo malignancy prior to transplantation, with the exception of treated effectively basal cell or squamous cell carcinomas of the skin,- Current participation at another clinical study, - All clinical condition that the investigator considers incompatible with the conduct of the study in acceptable security conditions, - Inability of patient to comply with study procedures, - Pregnant or breast-feeding women, - Person placed under guardianship, under protection of law.

Additional Information

Official title Impact of the Absence of Steroids on the Evolution of Renal Function and on the Progression of Graft Fibrosis, Quantified by Numerical Method, in Patients With Renal Transplant
Principal investigator Diego CANTAROVICH, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.