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

Takeda

Status: Enrolling

Conditions: Kidney Failure; Cytomegalovirus (CMV); Kidney Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06243731

TAK-620-4007

EUPAS1000000006 (Registry Identifier)

Details and patient eligibility

About

The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis).

In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults more than and equal to (≥) 18 years of age at index date.

• Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date.

  • If ESRD (including participants on peritoneal dialysis or hemodialysis): participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (<) 15 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).
  • If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to <30 mL/min/1.73m^2 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.

Trial design

10 participants in 1 patient group

All Participants With Kidney Failure

Description:

The study cohort will comprise of participants aged 18 years or older treated with maribavir for a refractory CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis. Data from eligible participants will be assessed from index date (Day 0: the day of initiation of the first maribavir treatment course during the eligibility period) until 7 days after the date of the end of supply of the last prescription of treatment or date of death or end of data availability, or treatment completion/discontinuation whichever occurs first.

Treatment:

Other: No Intervention