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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Absence of corticotherapy post-transplantation | Other | No study treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of which the blinded readings to treatment group are made by two independent anatomical pathologists, the Banff criteria 2009). | One year post-transplantation |
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Pre-Inclusion Criteria:
Inclusion criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lyon | Lyon | 69437 | France | |||
| Nantes University Hospital |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Corticotherapy post-transplantation | Drug | Prednisone or prednisolone orally for at least one year post-transplantation with the following minimal doses :
|
|
| Percentage of fibrosis of the graft. |
The percentage of fibrosis of the graft at one year post-transplantation (biopsy at one year with numerical reading of fibrosis by image analysis and blinded reading to treatment group by two independent anatomical pathologists, the Banff criteria 2009). |
| One year post-transplantation |
| Average glomerular filtration rate | The average glomerular filtration rate, calculated by the MDRD formula (four variables, Modification Diet in Renal Disease). | One year post-transplantation |
| Dialysis session | The percentage of patients with at least one dialysis session realised during the first year of transplant. | One year post-transplantation |
| Ratio of proteinuria/creatinuria | Average of ratio of proteinuria/creatininuria (mg / mmol). | One year post-transplantation |
| Episode of acute rejection | The percentage of patients with at least one episode of acute rejection during the first year after transplantation. We will distinguish biopsy-proven acute rejection (RABP), the corticosteroids resistant RABP and severe RABP (Banff 2009). | One year post-transplantation |
| Diagnosis of DSA | The percentage of patients with a diagnosis of DSA (Luminex® method) at 3 months and 1 year post-transplantation. | One year post-transplantation |
| Percentage of graft failure | The percentage of graft failure (death or return to dialysis) during the first year of transplantation (the short duration of the study avoids the management of right censoring). | One year post-transplantation |
| Difference between numerical reading of fibrosis and evaluation by anatomical pathologists | The difference between the percentage of graft fibrosis evaluated by numerical reading of fibrosis and that assessed by two independent anatomical pathologists (Banff 2009 criteria) at baseline, 3 months and 1 year post-transplantation. | One year post-transplantation |
| Number of adverse events | Adverse events (AE) at 12 months post-transplantation, of which AEs of special interest (NODAT, dyslipidemia, hypertension, CMV viral infections, BKV) with an assessment of vital signs, physical examinations and laboratory tests. | One year post-transplantation |
| Nantes |
| 44093 |
| France |
| CHU de Nice | Nice | 06000 | France |
| AP-HP - Hôpital Necker | Paris | 75743 | France |
| AP-HP - Hôpital Bicêtre | Paris | 94275 | France |
| CHU de Saint-Etienne | Saint-Etienne | 42270 | France |
| CHU de Toulouse | Toulouse | 31049 | France |
| CHRU de Tours | Tours | 37044 | France |