Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation (Astronef)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 4

Conditions: Renal Transplant

Treatments: Drug: Corticotherapy post-transplantation; Other: Absence of corticotherapy post-transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01541176

RC11_0013

Details and patient eligibility

About

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).

Enrollment: 193 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 2 patient groups

Absence of corticotherapy post-transplantation

Experimental group

Description:

All patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) without corticotherapy post-transplantation.

Treatment:

Other: Absence of corticotherapy post-transplantation

Corticotherapy post-transplantation

Active Comparator group

Description:

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.

Treatment:

Drug: Corticotherapy post-transplantation