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

Last updated: June 27, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Nephropathy

Cytomegalovirus Infections

Focal Segmental Glomerulosclerosis

Treatment

No Intervention

Clinical Study ID

NCT06243731
TAK-620-4007
EUPAS1000000006
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 filtrationrate (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 15to <30 mL/min/1.73m^2 at index.

  • Participant has undergone solid organ transplant (SOT) or hematopoietic stem celltransplantation (HSCT) before index date.

  • Participant was diagnosed with refractory (with or without resistance) CMV duringthe latest post-transplant period.

  • Participant initiated treatment with maribavir in routine practice within theeligibility period and received at least 1 dose of maribavir.

  • Informed consent provided (where required by local regulations) before datacollection commences.

Exclusion

Exclusion Criteria:

There are no exclusion criteria for this study.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
November 30, 2025
Estimated Completion Date:
January 31, 2027