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

ConditionsCytomegalovirus (CMV)Kidney Disease Kidney Failure

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorTakeda

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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/1.73m²).

If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to <30 mL/min/1.73m² at index.

Disqualifiers

None

Trial population

Participants treated with maribavir for a refractory (with or without resistance) CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

No Intervention
Other intervention
This is a non-interventional study.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: All Participants With Kidney Failure1 intervention

Trial outcomes

Primary outcomes

Number of Participants With Adverse Events (AEs)

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.

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)

Secondary outcomes

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

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.

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)