NCT01541176

Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2012-02-29
• Last updated: 2019-01-31

Locations

8 sites across 1 country: France