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Virus Therapy

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

Phase 4

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year following transplant

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year following transplant

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Pyrexia

Cough

Oedema peripheral

Hypokalaemia

Abdominal pain

Asthenia

Fatigue

Decreased appetite

Dysgeusia

Hypertension

Platelet count decreased

Pruritus

Dyspnoea

Headache

Renal impairment

Tremor

White blood cell count decreased

Blood creatinine increased

Constipation

Febrile neutropenia

Cystitis haemorrhagic

Taste disorder

Acute graft versus host disease in intestine

Acute lymphocytic leukaemia recurrent

Cytomegalovirus infection

Cytomegalovirus viraemia

Pneumonia

Pneumonia cytomegaloviral

Pseudomonal sepsis

Respiratory tract infection

Acute myeloid leukaemia recurrent

100%

80%

60%

40%

20%

Study treatment Arm

Valganciclovir 900 mg BID

Maribavir 400 mg BID

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,566 Total Patients Enrolled

TakedaIndustry Sponsor

1,203 Previous Clinical Trials

4,177,874 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Intervention a secure approach for individuals?

"Power's team rated Intervention as 3, indicating the highest level of safety due to its Phase 4 status and regulatory clearance."

Answered by AI

Are there currently any opportunities for patients to participate in this experiment?

"According to the clinicaltrials.gov portal, this medical study is no longer recruiting patients, having last been updated on September 5th 2023. On the bright side, there are a dozen other trials actively looking for new participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

David J. Taber 2023. "Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034925.

All > Cmv > Kidney Transplant