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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether Maribavir or Valganciclovir is more effective at preventing CMV infections in individuals who have recently undergone a kidney transplant. The researchers compare these treatments to assess not only their effectiveness but also their ease of use for patients. Individuals who have had a kidney transplant within the past week and are at risk for CMV may be suitable candidates for this study. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that maribavir is usually well-tolerated by people with CMV infections. Studies have found that maribavir effectively clears CMV infections in transplant patients, with most side effects being mild, such as changes in taste.

Valganciclovir, already approved by the FDA for preventing and treating CMV infections, has been used by many patients and is generally safe. Common side effects include low blood cell counts and diarrhea.

Both maribavir and valganciclovir have been tested extensively and are considered safe for most users. However, like any medication, they can have side effects. Consulting a healthcare provider is important to determine the best option. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about maribavir for preventing CMV infections in kidney transplant patients because it offers a different mechanism of action compared to current treatments like valganciclovir. While valganciclovir works by inhibiting viral DNA synthesis, maribavir targets and inhibits the CMV UL97 kinase, which is crucial for viral replication. This unique approach not only provides a new way to combat the virus but also has the potential to reduce some of the side effects associated with traditional antiviral drugs.

What evidence suggests that this trial's treatments could be effective for preventing CMV infection in kidney transplant patients?

This trial will compare Maribavir and Valganciclovir for preventing CMV infections in kidney transplant patients. Research has shown that Maribavir, which participants in this trial may receive, produces promising results in clearing CMV infections, especially in patients unresponsive to other treatments. Specifically, more than half of the patients treated with Maribavir eliminated the virus within eight weeks. This suggests that Maribavir can be effective for kidney transplant patients with CMV infections. In contrast, Valganciclovir, another treatment option in this trial, is already approved and commonly used to prevent and treat CMV infections. Its success in preventing CMV in kidney transplant patients is well-known. Both treatments offer potential benefits for preventing CMV infections in this context. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41018408/

A Randomized Controlled Trial Comparing the Tolerability ... A recent systematic review showed that with antiviral prophylaxis, early CMV infection occurred in only 6% of kidney recipients, and late ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1600613525030692

Determinants of Virological Outcomes in Kidney Transplant ... Maribavir has demonstrated promising efficacy in treating refractory cytomegalovirus (CMV) infections among solid organ transplant ...

3. jhltonline.org jhltonline.org/article/S1053-2498(24)01971-5/fulltext

Maribavir for refractory cytomegalovirus infection (with or ... A higher proportion of maribavir-treated patients achieved the primary endpoint than with IAT across transplant organ types, including kidney ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9464078/

Maribavir for Refractory Cytomegalovirus Infections With or ... A significantly higher proportion of patients in the maribavir group achieved confirmed CMV viremia clearance at week 8 than in the IAT group (55.7% [131/235] ...

5. amjtransplant.org amjtransplant.org/article/S1600-6135(25)01771-X/pdf

A Retrospective, Observational Analysis of Real-World ... Letermovir (LET), a novel CMV prophylactic agent, lacks myelosuppressive effects, but data in AA kidney transplant recipients (KTR) are limited. We present ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02931539

NCT02931539 | Efficacy and Safety Study of Maribavir ... The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06034925

Maribavir vs. Valganciclovir for CMV Prophylaxis in High ... Maribavir has been evaluated for the prevention of CMV infection in Phase II and Phase III trials within allogeneic stem cell transplant recipients. At 6-months ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0929664624002456

Prevention and management of cytomegalovirus infection ... Early trials of maribavir for preventing CMV infection in organ transplant recipients were unsuccessful. However, a 2022 phase III clinical trial published ...