Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06263218
Study type	Observational [Patient Registry]
Source	Hospital do Rim e Hipertensão
Contact
Status	Enrolling by invitation
Phase
Start date	October 1, 2023
Completion date	December 29, 2024

View Details

See also
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