Clinical trial NCT06243731: A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cytomegalovirus (CMV)
Kidney Disease
Kidney Failure
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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 outcomes:
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: