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

Not yet recruiting

• Conditions: Cytomegalovirus (CMV); Kidney Failure; Kidney Disease
• Interventions: Other: No Intervention

• Registration Number: NCT06243731
• Lead Sponsor: Takeda

Brief Summary

The main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or ESRD) or have severe chronic kidney disease requiring 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Study Start: 2025-05-30
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants With Kidney Failure	No Intervention	Participants aged 18 years or older treated with maribavir for a refractory CMV infection and who have comorbid ESRD or severe chronic renal disease requiring peritoneal dialysis or hemodialysis will be assessed from index date (Day 0: the day of initiation of the first maribavir treatment course during the eligibility period) until, end of treatment (treatment completion, discontinuation, or addition of another antiviral regimen for CMV) +7 days post-treatment, death, or end of data availability whichever occurs earliest.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Time from index treatment date until end of treatment (treatment completion, discontinuation, or addition of another antiviral CMV regimen) +7 days post-treatment, death, or end of data availability whichever occurs earliest (up to 3 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 Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events of Special Interest (AESIs)	Time from index treatment date until end of treatment (treatment completion, discontinuation, or addition of another antiviral CMV regimen) +7 days post-treatment, death, or end of data availability whichever occurs earliest (up to 3 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).