Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06034925 |
Other study ID # |
Pro00125967 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
November 6, 2023 |
Est. completion date |
November 30, 2025 |
Study information
Verified date |
September 2023 |
Source |
Medical University of South Carolina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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).
Description:
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 post-transplant, the
rates of CMV infection using PCR were not different between treatment and placebo arms,
although the rates of pp65 antigenemia were lower in the Maribavir group. However, these
studies used a low dose of 100mg PO BID. In subsequent studies within solid organ
transplantation, Maribavir dosed at 400 to 1200mg PO BID was equally efficacious to
valganciclovir for the treatment of CMV infection. Of note and importance to this proposal,
the rates of neutropenia were 4-5% in the Maribavir treated patients vs. 15-18% in
Valganciclovir patients. Thus, at an appropriate dose, Maribavir appears to have similar
efficacy to Valganciclovir in treating CMV infection with a significantly reduced incidence
of neutropenia. Currently, there is a lack of randomized controlled trials assessing the
safety and efficacy of adequately dosed (=400mg PO BID) Maribavir for the prevention of CMV
infection in solid organ transplant recipients.
Aim 1. Assess the incidence of leukopenia in those randomized to Maribavir vs. Valganciclovir
prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
Hypothesis 1. The incidence of clinically meaningful leukopenia, defined as a WBC count of <
3,000 cells/mm3 and a reduction in total mycophenolate dose below 1,500 mg/day or
valganciclovir dose below 900mg per day (adjusted for renal function), will be significantly
lower in the Maribavir arm, as compared to the Valganciclovir arm.
Aim 2. Assess the efficacy of Maribavir vs. Valganciclovir prophylaxis in adult kidney
transplant recipients at high-risk of CMV infection.
Hypothesis 2. The incidence of CMV infection and disease will be similar between the
Maribavir arm, as compared to the Valganciclovir arm, at 3-, 6-, and 12-months
post-transplant.
Aim 3. Assess the impact of Maribavir vs. Valganciclovir prophylaxis on healthcare
utilization and costs in adult kidney transplant recipients at high-risk of CMV infection.
Hypothesis 3. Healthcare utilization will be lower in the Maribavir arm, as compared to the
Valganciclovir arm, at 6- and 12-months post-transplant, driven predominantly by reduced
number of telephone calls, televisits, and laboratory monitoring encounters.
Exploratory Aim 4. Assess the impact of Maribavir vs. Valganciclovir prophylaxis in adult
kidney transplant recipients at high-risk of CMV infection on patient-reported outcomes for
quality of life and satisfaction.
Exploratory Aim 5. Assess any differences in leukopenia, efficacy, healthcare utilization and
patient reported outcomes by race and sex in patients randomized to Maribavir vs.
Valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV
infection.