Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

PHASE4CompletedINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

May 2, 2014

Primary Completion Date

October 10, 2018

Study Completion Date

October 10, 2018

Conditions
Transplantation InfectionCytomegalovirus Infection
Interventions
DRUG

Everolimus

"Everolimus : 0.75 bid, targeted to 3-8 ng/ml~Cyclosporin A :~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.~Corticosteroids :~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg"

DRUG

mycophenolic acid

"Mycophenolic acid :~1080 mg bid for one month, then 720 mg bid~Cyclosporin A :~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.~Corticosteroids :~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg"

Trial Locations (9)

14033

CHRU Caen - Hôpital de Caen, Caen

29609

CHU La Cavale Blanche, Brest

31000

CHU de Toulouse - Hôpital Rangueil, Toulouse

33000

CHU de Bordeaux, Bordeaux

69003

Hôpital Edouard Herriot, Lyon

75015

APHP - Hôpital Necker, Paris

94275

APHP - Kremlin Bicetre, Paris

Unknown

CHU de Limoges - Hôpital Dupuytren, Limoges

CHRU Strasbourg, Strasbourg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

University Hospital, Bordeaux

OTHER