An observational study in CMV Infection and CMV Viremia, sponsored by Hospital do Rim e Hipertensão. Enrolling by invitation at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Hospital do Rim e Hipertensão · Observational
Among 12 studies in Cytomegalovirus Infections with a site in Brazil — 1 open to participants now, 1 under way, none of them phase 3. Cytomegalovirus Infections · Brazil.
Among the 12 studies in Cytomegalovirus Infections with a site in Brazil, this one is the only one that started in 2023, is one of 5 observational ones, and was the 12th registered.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
This study's planned enrollment of 500 is above the median of 150 across 93 observational studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →1 of the 12 studies in Cytomegalovirus Infections with a site in Brazil is open now, in 1 country. Each count lists the studies.
Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2023.
Median enrollment 250 across the 7 interventional studies, 150 across the 5 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
3 of 12 have an industry lead sponsor. The 7 most frequent:
Hospital do Rim e Hipertensão is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Hospital do Rim e Hipertensão has 4 studies filed under Cytomegalovirus Infections — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Cytomegalovirus Infections with a site in Brazil, from their registry updates:
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.
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Incidence of infection, CMV disease, and tissue invasive disease.
Incidence of infection, CMV disease, and tissue invasive disease.
Time frame: 12 months
Incidence recurrent CMV infection/disease
Incidence recurrent CMV infection/disease
Time frame: 12 months
Incidence of refractory CMV infection/disease
Incidence of refractory CMV infection/disease
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Jul 2024, 9 months after the start.
Of 30 observational studies under Cytomegalovirus Infections, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 61. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Hospital do Rim e Hipertensão