Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation

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).

Conditions

• Renal Transplant

Interventions

OTHER

Absence of corticotherapy post-transplantation

No study treatment

DRUG

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.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Diego CANTAROVICH, MD, PhD · Nantes University Hospital

• Lionel ROSTAING, Profesor · University Hospital, Toulouse

• Christophe LEGENDRE, Profesor · Hôpital Necker (AP-HP)

• Emmanuel MORELON, Profesor · Hospices Civils de Lyon

• Elisabeth CASSUTO-VIGUIER, Doctor · Centre Hospitalier Universitaire de Nice

• Christophe MARIAT, Profesor · CHU de Saint-Etienne

• Matthias BÜCHLER, Profesor · CHRU de Tours

• Antoine DURRBACH, Profesor · Hôpital Bicêtre (AP-HP)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• France

Study Locations