Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia.

PHASE4CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

January 15, 2018

Primary Completion Date

August 1, 2024

Study Completion Date

August 1, 2024

Conditions
BK Virus Nephropathy After Kidney Transplantation
Interventions
DRUG

everolimus

Patients with viremia above 2.8 log of copies/ml will be randomized (ratio 1:1) into either of 2 groups Group 1 : control group : immunosuppression lowering or Group 2 : experimental group : immunosuppression lowering and replacement of mycophenolate acid by everolimus Evolution of BKV viremia and allograft function will be assessed during 2 years after randomization

Trial Locations (15)

14033

CHU Côte de Nacre, Caen

29609

CHU - Hôpital de la Cavale Blanche, Brest

35033

CHU Rennes - Hôpital Pontchaillou, Rennes

37044

CHRU - Hôpital Bretonneau, Tours

49033

CHRU d'Angers, Angers

51092

CHU - Hôpital Maison Blanche, Reims

63000

CHU Hôpital Gabriel Montpied, Clermont-Ferrand

67000

Les Hôpitaux Universitaires, Strasbourg

69003

Hôpital Edouard Herriot, Lyon

75743

AP-HP Hôpital Necker, Paris

75908

AP-HP - Hôpital Georges Pompidou, Paris

76230

CHU - Hôpital de la Cavale Blanche, Bois-Guillaume

80054

CHU - Hôpital Sud, Amiens

86021

CHU Poitiers - Hôpital Jean Bernard, Poitiers

87042

CHU - Hôpital Dupuytren, Limoges

All Listed Sponsors
lead

University Hospital, Strasbourg, France

OTHER

NCT03216967 - Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia. | Biotech Hunter | Biotech Hunter