A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

Launched by TAKEDA · Jan 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called maribavir to see how safe it is for adults with kidney failure who have a type of viral infection known as cytomegalovirus (CMV) after receiving a kidney transplant. The study will review existing medical records to gather information, meaning it won't change the usual care participants receive. The goal is to better understand how maribavir works for those who have this infection that hasn't responded to other treatments.

To join this study, participants must be adults aged 18 or older who have been diagnosed with end-stage renal disease (where the kidneys are no longer functioning well) or severe chronic kidney disease that requires dialysis. They also need to have received a solid organ transplant or a stem cell transplant and been treated for CMV infection with maribavir. There are no specific exclusions for this trial, and participants can expect that their regular medical care will continue without any changes due to the study.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Adults more than and equal to (≥) 18 years of age at index date
• • Diagnosis of ESRD or severe chronic renal disease prior to the index date
• • If ESRD: participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (\<) 15 milliliter per minute (mL/min)
• • If severe chronic renal disease: participant diagnosed with severe chronic renal disease requiring peritoneal dialysis or hemodialysis; participant has an eGFR of 15 to \<30 mL/min at index
• • Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date
• • Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period
• • Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir
• • Informed consent provided (where required by local regulations) before data collection commences
• • Exclusion Criteria
• • There are no exclusion criteria for this study