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Virus Therapy

Maribavir vs. Valganciclovir for CMV Infection Prevention in Kidney Transplant Patients

Phase 4
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received at least one dose of rATG induction or patient is D+/R- CMV serostatus
Kidney transplant recipient at study institution
Must not have
Age <18 years at time of transplant
Recipient of pancreas, liver, heart, lung transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year following transplant
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two meds to prevent CMV infections in kidney transplant recipients, Valganciclovir vs Maribavir+Acyclovir.

Who is the study for?
This trial is for adult kidney transplant recipients at the study institution who are within 7 days post-transplant and have either received a dose of rATG induction or have D+/R- CMV serostatus. It's not open to those under 18, recipients of other organ transplants, or patients on non-FDA approved investigational meds.
What is being tested?
The study compares two drug regimens for preventing CMV infections in high-risk kidney transplant patients: standard Valganciclovir versus Maribavir plus Acyclovir. Both drugs are FDA approved; one for prevention and treatment (Valganciclovir) and the other just for treatment (Maribavir) of CMV.
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea and diarrhea, blood cell count changes leading to anemia or low white cells increasing infection risk, liver function abnormalities, headaches, insomnia, fever, coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received rATG treatment or I am at high risk for CMV infection.
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I received a kidney transplant at this hospital.
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I am within 7 days post-transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old at the time of my transplant.
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I have received an organ transplant (pancreas, liver, heart, or lung).
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I have taken a medication for my condition that is not approved by the FDA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year following transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year following transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
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.

Side effects data

From 2022 Phase 3 trial • 553 Patients • NCT02927067
53%
Neutropenia
23%
Thrombocytopenia
23%
Nausea
18%
Anaemia
17%
Vomiting
16%
Diarrhoea
12%
Acute graft versus host disease in skin
11%
Neutrophil count decreased
10%
Leukopenia
9%
Pyrexia
9%
Cough
9%
Oedema peripheral
8%
Hypokalaemia
7%
Abdominal pain
7%
Asthenia
7%
Fatigue
6%
Decreased appetite
6%
Dysgeusia
6%
Hypertension
6%
Platelet count decreased
6%
Pruritus
5%
Dyspnoea
5%
Headache
5%
Renal impairment
5%
Tremor
5%
White blood cell count decreased
4%
Blood creatinine increased
4%
Constipation
3%
Febrile neutropenia
2%
Cystitis haemorrhagic
2%
Taste disorder
1%
Acute graft versus host disease in intestine
1%
Acute lymphocytic leukaemia recurrent
1%
Cytomegalovirus infection
1%
Cytomegalovirus viraemia
1%
Pneumonia
1%
Pneumonia cytomegaloviral
1%
Pseudomonal sepsis
1%
Respiratory tract infection
1%
Acute myeloid leukaemia recurrent
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valganciclovir 900 mg BID
Maribavir 400 mg BID

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
maribavir 400mg twice daily
Group II: ControlActive Control1 Intervention
valganciclovir 900mg once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maribavir
2017
Completed Phase 3
~1230

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
977 Previous Clinical Trials
7,400,917 Total Patients Enrolled
TakedaIndustry Sponsor
1,238 Previous Clinical Trials
4,148,948 Total Patients Enrolled
~32 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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