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

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Disqualifiers: Under 18, Pancreas transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are Valganciclovir (FDA approved to prevent and treat CMV infection) vs Maribavir (FDA approved to treat CMV infection) plus Acyclovir (FDA approved to prevent HSV infection).

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Valganciclovir for preventing CMV infection in kidney transplant patients?

Research shows that Valganciclovir significantly reduces the risk of CMV infection and disease in kidney transplant patients compared to no treatment. It is also more effective than Valacyclovir and has been shown to be safe and cost-effective, especially in low-dose forms. ^{1 2 3 4 5}

Is valganciclovir safe for preventing CMV infection in kidney transplant patients?

Valganciclovir is generally considered safe for preventing CMV infection in kidney transplant patients, with studies showing it effectively reduces infection risk and is well-tolerated. Low-dose valganciclovir is as safe as the standard dose and may have fewer side effects like neutropenia (low white blood cell count). ^{1 4 6 7 8}

How does the drug Maribavir differ from Valganciclovir in preventing CMV infection in kidney transplant patients?

Maribavir is unique because it works by inhibiting a different viral enzyme compared to Valganciclovir, which targets viral DNA replication. This difference in mechanism may offer an alternative for patients who cannot tolerate or do not respond well to Valganciclovir. ^{1 3 4 9 10}

Eligibility Criteria

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.

Inclusion Criteria

I have received rATG treatment or I am at high risk for CMV infection.

I received a kidney transplant at this hospital.

I am within 7 days post-transplant.

Exclusion Criteria

I am under 18 years old at the time of my transplant.

I have received an organ transplant (pancreas, liver, heart, or lung).

I have taken a medication for my condition that is not approved by the FDA.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Maribavir or Valganciclovir for CMV prophylaxis

12 months

Regular visits for monitoring and medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Periodic visits for follow-up assessments

Treatment Details

Interventions

• Maribavir
• Valganciclovir

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

maribavir 400mg twice daily

Group II: Control Active Control 1 Intervention

valganciclovir 900mg once daily

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of conventional antiviral agents in preventive strategies for cytomegalovirus infection after kidney transplantation: a systematic review and network meta-analysis. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

[The evaluation of cost-effectiveness and cost-utility of valganciclovir for the prophylaxis of cytomegalovirus disease to 200 days after kidney transplantation]. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Six months anti-viral prophylaxis significantly decreased cytomegalovirus disease compared with no anti-viral prophylaxis following renal transplantation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Low-Dose Valganciclovir Prophylaxis Is Safe and Cost-Saving in CMV-Seropositive Kidney Transplant Recipients. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Clinical outcomes of valganciclovir prophylaxis in high-risk (D+/R-) renal transplant recipients experiencing delayed graft function. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A randomized prospective controlled trial of oral ganciclovir versus oral valacyclovir for prophylaxis of cytomegalovirus disease after renal transplantation. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Antiviral Agents in Preventing Allograft Rejection Following CMV Prophylaxis in High-Risk Kidney Transplantation: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Prospective comparison of valacyclovir and oral ganciclovir for prevention of cytomegalovirus disease in high-risk renal transplant recipients. [2018]

9. North Macedonia pubmed.ncbi.nlm.nih.gov

A Comparison of Different Valgancyclovir Formulations in the Universal 6-Month Prophylaxis Against CMV Infection in Renal Transplant Recipients: A Randomized Single-Centre Study. [2020]

10. Denmark pubmed.ncbi.nlm.nih.gov

Cytomegalovirus prophylaxis in pediatric kidney transplantation: the Dutch experience. [2018]