Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure

NACompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 30, 2021

Study Completion Date

November 30, 2021

Conditions
Renal Transplantation
Interventions
PROCEDURE

Systematic transplantectomy

Transplantectomy within two months after return to dialyse. Antiproliferatives stop at the start of dialysis. Maintenance basic immunosuppressive treatment without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of the basic immunosuppressive treatment ttwo weeks after transplantectomy. Maintenance corticosteroids at 5mg per day until one month after transplantectomy then stop corticosteroids within one month.

PROCEDURE

Progressive reduction of immunosuppression

"Progressive reduction of immunosuppression. Transplantectomy for cause only. Antiproliferatives withdrawn at the start of dialysis. Maintenance of anticalcineurin or mTOR inhibitors half dose for 3 months, ¼ dose for 3 months and then stop. Maintenance corticosteroids for 6 months up to 5 mg per day, and then soft stop in 3 months.~In case of transplantectomy by reason in the control group, basic immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later, similary to the strategy used in the study group."

Trial Locations (9)

34295

Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie, Montpellier

37044

Service de Néphrologie, Immunologie Clinique - CHU Bretonneau, Tours

38043

Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon, Grenoble

42055

Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital Nord, Saint-Etienne

44093

Institut de Transplantation, Urologie et Néphrologie - CHU Nantes, Nantes

63000

Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied, Clermont-Ferrand

67091

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

69003

Transplantation Department, Hôpital Edourad Herriot, Lyon

74374

Service de Néphrologie-Dialyse, Centre Hospitalier d'Annecy, Pringy

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT01817504 - Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure | Biotech Hunter | Biotech Hunter