Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation

NCT01541176 | Completed Phase 4 DMC

• 1 other identifier: RC11_0013
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 8

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

Keywords

Corticotherapy; Fibrosis; Numerical reading; 18-70 years; first renal transplant was lost due to rejection; first or second renal transplant

Outcome Measures

Primary Outcomes (1)

• Percentage of fibrosis of the graft

  Evolution of the percentage of fibrosis of the graft during the first year after transplantation (pre-transplant biopsy versus biopsy at one year), by numerical reading of fibrosis by image analysis.

  One year post-transplantation

Secondary Outcomes (10)

• Percentage of fibrosis of the graft

  One year post-transplantation

• Percentage of fibrosis of the graft.

  One year post-transplantation

• Average glomerular filtration rate

  One year post-transplantation

• Dialysis session

  One year post-transplantation

• Ratio of proteinuria/creatinuria

  One year post-transplantation

Study Arms (2)

Absence of corticotherapy post-transplantation

EXPERIMENTAL

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

Other: Absence of corticotherapy post-transplantation

Corticotherapy post-transplantation

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.

Drug: Corticotherapy post-transplantation

Interventions

Absence of corticotherapy post-transplantation OTHER

No study treatment

Absence of corticotherapy post-transplantation

Corticotherapy post-transplantation 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.

Corticotherapy post-transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (8)

CHU de Lyon

Lyon, 69437, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

CHU de Nice

Nice, 06000, France

Location

AP-HP - Hôpital Necker

Paris, 75743, France

Location

AP-HP - Hôpital Bicêtre

Paris, 94275, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42270, France

Location

CHU de Toulouse

Toulouse, 31049, France

Location

CHRU de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diego CANTAROVICH, MD, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Lionel ROSTAING, Profesor

  University Hospital, Toulouse

  STUDY CHAIR

• Christophe LEGENDRE, Profesor

  Hôpital Necker (AP-HP)

  STUDY CHAIR

• Emmanuel MORELON, Profesor

  Hospices Civils de Lyon

  STUDY CHAIR

• Elisabeth CASSUTO-VIGUIER, Doctor

  Centre Hospitalier Universitaire de Nice

  STUDY CHAIR

• Christophe MARIAT, Profesor

  CHU de Saint-Etienne

  STUDY CHAIR

• Matthias BÜCHLER, Profesor

  CHRU de Tours

  STUDY CHAIR

• Antoine DURRBACH, Profesor

  Hôpital Bicêtre (AP-HP)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

FR (8)