Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

• Conditions: CMV Infection; CMV Viremia

• Registration Number: NCT06263218
• Lead Sponsor: Hospital do Rim e Hipertensão

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

Study Timeline

• Study First Submitted: 2023-09-21
• Study Start: 2023-10-01
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-16
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-07-30
• Study Completion: 2024-12-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of infection, CMV disease, and tissue invasive disease.	12 months	Incidence of infection, CMV disease, and tissue invasive disease.

Secondary Outcome Measures

Name	Time	Method
Incidence recurrent CMV infection/disease	12 months	Incidence recurrent CMV infection/disease
Incidence of refractory CMV infection/disease	12 months	Incidence of refractory CMV infection/disease

Trial Locations

Locations (1)

Hospital do Rim; 🇧🇷 São Paulo, Brazil