Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

NCT06263218 | Enrolling By Invitation

• 1 other identifier: CCR-2023-200344
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

CMV Infection; CMV Viremia

Outcome Measures

Primary Outcomes (1)

• Incidence of infection, CMV disease, and tissue invasive disease.

  Incidence of infection, CMV disease, and tissue invasive disease.

  12 months

Secondary Outcomes (2)

• Incidence recurrent CMV infection/disease

  12 months

• Incidence of refractory CMV infection/disease

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Rim e Hipertensão: lead

Study Sites (1)

Hospital do Rim

São Paulo, 04038-002, Brazil

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: February 16, 2024
• Study Start: October 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 29, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)