Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

CMV Infection Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06263218
• Other study ID #: CCR-2023-200344
• Status: Enrolling by invitation
• Start date: October 1, 2023
• Est. completion date: December 29, 2024

Study information

• Verified date: February 2024
• Source: Hospital do Rim e Hipertensão
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 29, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CMV Infection
• CMV Viremia
• Cytomegalovirus Infections
• Infections
• Viremia

Locations

Country	Name	City	State
Brazil	Hospital do Rim	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Rim e Hipertensão

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infection, CMV disease, and tissue invasive disease.	Incidence of infection, CMV disease, and tissue invasive disease.	12 months
Secondary	Incidence recurrent CMV infection/disease	Incidence recurrent CMV infection/disease	12 months
Secondary	Incidence of refractory CMV infection/disease	Incidence of refractory CMV infection/disease	12 months