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

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243731
• Other study ID #: TAK-620-4007
• Secondary ID: EUPAS1000000006
• Status: Not yet recruiting
• Start date: May 30, 2025
• Est. completion date: January 31, 2027

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus (CMV)
• Cytomegalovirus Infections
• Kidney Disease
• Kidney Diseases
• Kidney Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

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