CMV InfectionNCT06263218
Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil
An observational study of CMV Infection and CMV Viremia, run by Hospital do Rim e Hipertensão at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection, CMV Viremia
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2023to 29 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- CMV Infection, CMV Viremia
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infection, CMV disease, and tissue invasive disease.
Incidence of infection, CMV disease, and tissue invasive disease.
Measured: 12 months
Secondary outcomes (2)
Incidence recurrent CMV infection/disease
Incidence recurrent CMV infection/disease
Measured: 12 months
Incidence of refractory CMV infection/disease
Incidence of refractory CMV infection/disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Oct 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital do Rim e Hipertensão
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263218
- Sponsor's protocol ID
- CCR-2023-200344
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No