Clinical trial NCT06263218: Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil
Official title: Single-center, Non-interventional, Retrospective Study on the Outcomes of Infection by CMV, Treatment Patterns, and Healthcare Resource Utilization Among CMV Recipients Kidney Transplant in Brazil
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: CMV Infection
CMV Viremia
Lead sponsor: Hospital do Rim e Hipertensão
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be entirely adult kidney transplant recipients (age ≥18 years at the time of time of transplantation) who developed a first episode of CMV infection/disease in the first year of transplant. Eligible individuals will be enrolled consecutively based on transplant date, starting from the first year as defined in the inclusion/exclusion criteria.

Brief summary: This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable.

Detailed description: Data will be collected from medical records and will include transplant recipient characteristics, transplant-related information, CMV status, clinical outcomes, treatment patterns, healthcare resource utilization and captured on an electronic Intake Form.

Study-specific Case Report (eCRF) The sponsor will create a Statistical Analysis Plan (SAP) before collection begins of data. The eCRF system will comply with research regulations

Eligibility criteria: Inclusion Criteria:

* Received a single kidney transplant after January 1, 2018
* Age over 18 years at time of kidney transplant.
* It was under preemptive strategy.
* Diagnosed with CMV infection/disease within the first 12 months after kidney transplant.
* Follow-up information is available in medical records for at least 12 months after confirmation of CMV infection, or even loss of the allograft, death of the recipient or loss of follow-up of the receiver, when/if applicable.

Exclusion Criteria:

* Diagnosed as a carrier of the human immunodeficiency virus (HIV+), hepatitis B virus and/or hepatitis C before kidney transplantation.
* Participation in any interventional study during the period between kidney transplantation and a period of 12 months after CMV diagnosis.

Primary outcomes:
measure: Incidence of infection, CMV disease, and tissue invasive disease.
timeFrame: 12 months
Secondary outcomes:
measure: Incidence recurrent CMV infection/disease
timeFrame: 12 months
measure: Incidence of refractory CMV infection/disease
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Rim
Study officials:
References: