TAK-620-4007: Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Severe Chronic Kidney Disease (CKD) or Comorbid End-stage Renal Disease (ESRD), Including Patients on Peritoneal Dialysis or Hemodialysis

Study identification

• EU PAS number:
  EUPAS1000000006
• Study ID:
  1000000006
• Official title and acronym:
  TAK-620-4007: Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Severe Chronic Kidney Disease (CKD) or Comorbid End-stage Renal Disease (ESRD), Including Patients on Peritoneal Dialysis or Hemodialysis
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  Estonia

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  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.;
• Study status:
  Planned

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 30/05/2025

Study start date

Planned: 30/11/2025

Data analysis start date

Planned: 01/01/2026

Date of interim report, if expected

Planned: 28/02/2026

Date of final study report

Planned: 31/01/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)