3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

346

Participants

Timeline

Start Date

September 2, 2015

Primary Completion Date

June 21, 2024

Study Completion Date

June 21, 2024

Conditions
Renal Transplantation
Interventions
DRUG

Corticosteroid boluses Methylprednisolone

"Intensification of the corticotherapy in accordance with the validated protocol for the treatment of classic and subclinical acute rejections: 3 bolus Methylprednisolone 500 mg IV at D1, D2 and D3 then decreasing during 10-15 days at 1mg/kg/d and down to the maintenance dose.~An anti-pneumocystis and anti-CMV prophylaxis will be systemically introduced for 3 months.~The rest of maintenance immunosuppressive regimen (mycophenolate mofetil and anti-calcineurin) will remain unaltered"

OTHER

No therapeutic modification

No therapeutic modification: continuation of the corticotherapy at the maintenance dose and maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin).

OTHER

Stop maintenance corticotherapy

Immediate withdrawal of maintenance corticotherapy. Maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin).

Trial Locations (8)

29609

Service de Néphrologie, Hémodialyse, Transplantations Rénales - Hôpital de la Cavale Blanche - CHU de Brest, Brest

31059

Département de Néphrologie et Transplantation d'Organes - Hôpital Rangueil - CHU de Toulouse, Toulouse

33000

Service de Néphrologie,Transplantation, Dialyse I - Hôpital Pellegrin - CHU Bordeaux, Bordeaux

44093

Institut de Transplantation, Urologie et Néphrologie (ITUN) - CHU de Nantes, Nantes

59037

Service de Néphrologie - Hôpital Claude Huriez - CHU de Lille, Lille

67091

Service de Néphrologie et Transplantation - Nouvel Hôpital Civil - CHRU Strasbourg, Strasbourg

69437

Service de Néphrologie, Transplantation et Immunologie Clinique - Hôpital Edouard Herriot - Hospices Civils de Lyon, Lyon

75015

Service de Transplantation - Hôpital Universitaire Necker, Paris

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02444429 - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation | Biotech Hunter | Biotech Hunter