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Trial Outcomes & Findings for Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients (NCT NCT06034925)

NCT ID: NCT06034925

Last Updated: 2026-04-30

Results Overview

Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection. Clinically significant leukopenia is defined as a white blood cell count that is \<3,000 cells/mm3 with an adjustment in either mycophenolate or the antiviral prophylaxis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

One year following transplant

Results posted on

2026-04-30

Participant Flow

Participant milestones

Participant milestones
Measure
Control
valganciclovir 900mg once daily
Intervention
maribavir 400mg twice daily
Overall Study
STARTED
35
35
Overall Study
COMPLETED
35
35
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=35 Participants
valganciclovir 900mg once daily
Intervention
n=35 Participants
maribavir 400mg twice daily
Total
n=70 Participants
Total of all reporting groups
Age, Continuous
51 years
STANDARD_DEVIATION 11 • n=14 Participants
57 years
STANDARD_DEVIATION 10 • n=34 Participants
54 years
STANDARD_DEVIATION 10 • n=69 Participants
Sex: Female, Male
Female
13 Participants
n=14 Participants
10 Participants
n=34 Participants
23 Participants
n=69 Participants
Sex: Female, Male
Male
22 Participants
n=14 Participants
25 Participants
n=34 Participants
47 Participants
n=69 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=14 Participants
0 Participants
n=34 Participants
0 Participants
n=69 Participants
Race (NIH/OMB)
Asian
0 Participants
n=14 Participants
0 Participants
n=34 Participants
0 Participants
n=69 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=14 Participants
0 Participants
n=34 Participants
0 Participants
n=69 Participants
Race (NIH/OMB)
Black or African American
25 Participants
n=14 Participants
25 Participants
n=34 Participants
50 Participants
n=69 Participants
Race (NIH/OMB)
White
10 Participants
n=14 Participants
10 Participants
n=34 Participants
20 Participants
n=69 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=14 Participants
0 Participants
n=34 Participants
0 Participants
n=69 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=14 Participants
0 Participants
n=34 Participants
0 Participants
n=69 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=14 Participants
0 Participants
n=34 Participants
1 Participants
n=69 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants
n=14 Participants
35 Participants
n=34 Participants
69 Participants
n=69 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=14 Participants
0 Participants
n=34 Participants
0 Participants
n=69 Participants

PRIMARY outcome

Timeframe: One year following transplant

Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection. Clinically significant leukopenia is defined as a white blood cell count that is \<3,000 cells/mm3 with an adjustment in either mycophenolate or the antiviral prophylaxis.

Outcome measures

Outcome measures
Measure
Intervention
n=35 Participants
maribavir 400mg twice daily
Control
n=35 Participants
valganciclovir 900mg once daily
Clinical Significant Leukopenia
1 Participants
8 Participants

PRIMARY outcome

Timeframe: One year following transplant

CMV infection is defined as having at least one CMV DNA PCR test of \>1000 copies/mL. Compare the proportion of patients that develop cytomegalovirus (CMV) infection in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.

Outcome measures

Outcome measures
Measure
Intervention
n=35 Participants
maribavir 400mg twice daily
Control
n=35 Participants
valganciclovir 900mg once daily
CMV Infection
11 Participants
8 Participants

Adverse Events

Control

Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths

Intervention

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Control
n=35 participants at risk
valganciclovir 900mg once daily
Intervention
n=35 participants at risk
maribavir 400mg twice daily
Renal and urinary disorders
Graft Loss
5.7%
2/35 • 1 year
Moderate or severe AEs - defined as those requiring intervention.
2.9%
1/35 • 1 year
Moderate or severe AEs - defined as those requiring intervention.

Other adverse events

Adverse event data not reported

Additional Information

Professor

Medical University of South Carolina

Phone: 8437922724

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place