Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

July 22, 2025

Primary Completion Date

January 31, 2029

Study Completion Date

June 30, 2031

Conditions
Cytomegalovirus (CMV)Kidney Transplant; ComplicationsKidney Diseases
Interventions
DRUG

Valganciclovir (Pre-emptive CMV Therapy)

Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.

DRUG

Valganciclovir CMV Prophylaxis

Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 200 days post transplantation as prophylaxis.

Trial Locations (5)

23219

RECRUITING

Medical College of Virginia Commonwealth, Richmond

30322

RECRUITING

Emory University School of Medicine, Atlanta

33136

RECRUITING

University of Miami Miller School of Medicine, Miami

94117

RECRUITING

University of California, San Francisco School of Medicine, San Francisco

07039

RECRUITING

Robert Wood Johnson Health Network Barnabas Health, Livingston

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of California, San Francisco

OTHER