Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation

NCT ID: NCT01541176

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2018-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Absence of corticotherapy post-transplantation

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

Group Type: EXPERIMENTAL

Absence of corticotherapy post-transplantation

Intervention Type: OTHER

No study treatment

Corticotherapy post-transplantation

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.

Group Type: ACTIVE_COMPARATOR

Corticotherapy post-transplantation

Intervention Type: DRUG

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.

Interventions

Absence of corticotherapy post-transplantation

No study treatment

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego CANTAROVICH, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Lionel ROSTAING, Profesor

Role: STUDY_CHAIR

University Hospital, Toulouse

Christophe LEGENDRE, Profesor

Role: STUDY_CHAIR

Hôpital Necker (AP-HP)

Emmanuel MORELON, Profesor

Role: STUDY_CHAIR

Hospices Civils de Lyon

Elisabeth CASSUTO-VIGUIER, Doctor

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Nice

Christophe MARIAT, Profesor

Role: STUDY_CHAIR

CHU de Saint-Etienne

Matthias BÜCHLER, Profesor

Role: STUDY_CHAIR

CHRU de Tours

Antoine DURRBACH, Profesor

Role: STUDY_CHAIR

Hôpital Bicêtre (AP-HP)

Locations

CHU de Lyon

Lyon, , France

Nantes University Hospital

Nantes, , France

CHU de Nice

Nice, , France

AP-HP - Hôpital Necker

Paris, , France

AP-HP - Hôpital Bicêtre

Paris, , France

CHU de Saint-Etienne

Saint-Etienne, , France

CHU de Toulouse

Toulouse, , France

CHRU de Tours

Tours, , France

Countries

France

Other Identifiers

RC11_0013

Identifier Type: -

Identifier Source: org_study_id