Letermovir vs Valganciclovir in CMV R+ Kidney Transplant
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorElisabeth Kincaide
About this trial
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
* Is letermovir easier for patients to tolerate than valganciclovir? * How long does it take for a CMV infection to appear in each group? * Are there differences in "breakthrough" CMV infections between the two medications? * For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation
Disqualifiers
Multiorgan organ transplant
Received previous solid organ transplant or HSCT
Unable to take oral medications
Uncontrolled infections at the time of enrollment
Trial design
Design model
Parallel
Treatments tested in this trial
Letermovir
DrugLetermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant
Valganciclovir CMV Prophylaxis
DrugValganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: LetermovirActive comparator 1 intervention
Group B: ValganciclovirOther 1 intervention
Trial outcomes
Primary outcomes
1
CMV Infection
Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.
Time frame
12 months post kidney transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Elisabeth Kincaide
Lead sponsor
Bexar County Hospital District dba University Health
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: