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

Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Endstage Renal Disease (ESRD) or Comorbid Severe Chronic Renal Disease Requiring Peritoneal Dialysis or Hemodialysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Failure; Cytomegalovirus (CMV); Kidney Disease
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants treated with maribavir for a refractory (with or without resistance) CMV infection and who have comorbid ESRD or severe chronic renal disease requiring peritoneal dialysis or hemodialysis.

Description

Inclusion Criteria

• Adults more than and equal to (≥) 18 years of age at index date

• Diagnosis of ESRD or severe chronic renal disease prior to the index date

  • If ESRD: participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (<) 15 milliliter per minute (mL/min)
  • If severe chronic renal disease: participant diagnosed with severe chronic renal disease requiring peritoneal dialysis or hemodialysis; participant has an eGFR of 15 to <30 mL/min 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All Participants With Kidney Failure; 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.

Other: No Intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information about this study, click this link

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Urologic Diseases; DNA Virus Infections; Herpesviridae Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency; Cytomegalovirus Infections
• Other Study ID Numbers: TAK-620-4007; EUPAS1000000006 (Registry Identifier: EUPAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No