Actively Recruiting
Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus Infection and Severe Kidney Disease or Kidney Failure Including Dialysis
Led by Takeda · Updated on 2025-12-16
10
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of maribavir in adults who have severe chronic kidney disease CKD or end-stage renal disease ESRD, including those on dialysis, and who have a refractory cytomegalovirus CMV infection after transplantation. This observational study collects already existing data from participants medical records without changing their standard medical care or treatment. The study includes adults aged 18 years or older who have undergone solid organ or stem cell transplantation and have been treated with maribavir for refractory CMV infection. Data will be collected from the start of maribavir treatment through up to seven days after the last dose or until death or end of available data, whichever comes first. Participants include those with severe CKD or ESRD, including those on peritoneal or hemodialysis. Participants medical records will be reviewed to monitor any adverse events from maribavir treatment during the study period, which can last up to four years. The main measurement is the number of participants experiencing adverse events, including those of special interest. This review will not affect participants usual care, and no new treatments or interventions will be given as part of this study.
CONDITIONS
Brief Title
A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at the start of maribavir treatment
- Diagnosed with comorbid end-stage renal disease (ESRD) confirmed by eGFR less than 15 mL/min/1.73m2 or severe chronic kidney disease (CKD) with eGFR between 15 and less than 30 mL/min/1.73m2
- Have had a solid organ transplant or hematopoietic stem cell transplant before starting maribavir
- Diagnosed with refractory cytomegalovirus (CMV) infection during the latest post-transplant period
- Started maribavir treatment in routine practice and received at least one dose
- Provided informed consent where required before data collection begins
You will not qualify if you...
Research Team
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