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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06263218
- Acronym / sponsor ID
- CCR-2023-200344
- Conditions
- CMV Infection, CMV Viremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital do Rim e HipertensãoUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of infection, CMV disease, and tissue invasive disease.
Time frame: 12 months
Incidence of infection, CMV disease, and tissue invasive disease.
2 secondary outcomes
Incidence recurrent CMV infection/disease
Time frame: 12 months
Incidence of refractory CMV infection/disease
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV Infection and CMV Viremia, run by Hospital do Rim e Hipertensão at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection, CMV disease, and tissue invasive disease. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.