Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: CMV Infection; CMV Viremia

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04038-002
    • Hospital do Rim

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infection, CMV disease, and tissue invasive disease.	Incidence of infection, CMV disease, and tissue invasive disease.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence recurrent CMV infection/disease	Incidence recurrent CMV infection/disease	12 months
Incidence of refractory CMV infection/disease	Incidence of refractory CMV infection/disease	12 months

Collaborators and Investigators

• Sponsor: Hospital do Rim e Hipertensão

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): December 29, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Systemic Inflammatory Response Syndrome; Inflammation; DNA Virus Infections; Sepsis; Herpesviridae Infections; Infections; Viremia; Cytomegalovirus Infections
• Other Study ID Numbers: CCR-2023-200344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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