Cytomegalovirus InfectionsKidney and urinaryDrugPhase 3
What this study is
This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.
What's being tested
- Letermovir
Intervention · DRUG
480 mg taken orally once daily, for 84 days
Study details
- Official title
- An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
- Sponsor
- University of Wisconsin, Madison
- Conditions
- Cytomegalovirus Infections · Kidney Transplant Infection · Pancreas Transplant
- Enrolling
- 90 people
- Starts
- 2024-08-08
- Est. completion
- 2027-08
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Undergone kidney or simultaneous kidney/pancreas transplant
- High-risk CMV serostatus (D+/R-) at time of transplant
- Develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in the CMV stewardship monitoring initiative)
- Demonstrate proven or presumptive lack of CMI, either by CMI testing or risk factor screening
- Able to provide informed consent to participate
You can't join if
- Contraindication to letermovir or its excipients
- Develop ganciclovir-resistant CMV infection
- Currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent
- Unable or unwilling, in the opinion of the Investigator, to comply with the protocol
- Pregnant or breastfeeding
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openUW Hospital and Clinics
Madison, Wisconsin, United States
- Brad Astor, PhD · Sub-investigator
- Christopher Saddler, MD · Sub-investigator
- Jillian Descourouez, PharmD · Sub-investigator
Recruiting
Study team
Sponsor
University of Wisconsin, Madison
Study ID 2024-0174
Principal investigator
Sandesh Parajuli, MBBS
University of Wisconsin, Madison
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.