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

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.

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Key information

Conditions

Cytomegalovirus (CMV) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease Kidney Diseases Kidney Failure Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Erasme - PPDS, Anderlecht, Brussels Capital, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

Number of Participants With Adverse Events (AEs)

Time frame: Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years)

An AE is defined as any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) in a participant or clinical investigation participants administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is any event that results in: death; life-threatening event; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or a medically important event.

Secondary outcomes

Number of Participants With Adverse Events of Special Interest (AESIs)

Time frame: Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years)

An AESI is defined as AEs that will be specifically highlighted to the Investigator. AESIs are as follows: Immunosuppressant drug concentration level increased, tissue-invasive CMV disease, relapse or progression of the underlying disease for which the transplant was performed, taste disturbance (dysgeusia), Nausea, vomiting, diarrhea, invasive fungal or bacterial infections, graft-versus-host-disease (GVHD), leukopenia including neutropenia, lymphocytopenia, and low white blood cell (WBC) count, anemia including low hemoglobin and thrombocytopenia including low platelets count.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Feb 6, 2024
Registry last updated: Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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