Immune System Related Kidney Disease
NCT00001979
Chronic Disease, Disease Attributes
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT06828562
To establish a prospective, longitudinal cohort of participants who can provide blood, tissue (including kidney histology), urine samples to establish a core biobank for kidney disease research. Results from this biobank will be matched to clinical outcomes to facilitate the discovery (and/or validation) of novel prognostic, predictive or diagnostic biomarkers important for kidney disease.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Hypothesis:
Genetic ancestry influences the enrichment of certain polymorphisms, which may have important protective or adverse effects on important kidney related outcomes, including developing chronic kidney disease, progression to kidney failure, and/or poor long-term outcomes following kidney transplantation.
Aims:
To establish a prospective, longitudinal cohort of participants who can provide blood, tissue (including kidney histology), urine samples to establish a core biobank for kidney disease research. Results from this biobank will be matched to clinical outcomes to facilitate the discovery (and/or validation) of novel prognostic, predictive or diagnostic biomarkers important for kidney disease. Data from this cohort will be used to determine if genomic factors independently influence:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 20 years
Group 1 develops eGFR ≤ 60ml/min/1.73m2 (or biopsy proven kidney disease) ≥ 3-months, or albuminuria or proteinuria (UACR > 3mg/mmol or UPCR > 10mg/mmol) ≥ 3-months
Time frame: 20 years
For group 2, defined by eGFR decline ≥ 30% from baseline for ≥ 3 months, or eGFR decline to below 15ml/min/1.73m2 if baseline eGFR > 30ml/min/1.73m2, or the need for renal replacement therapy
Time frame: 20 years
For group 3 - either death (survival time on dialysis) if they do not receive a kidney transplant during the study, or if they receive a kidney transplant
Time frame: 20 years
death from any cause
Time frame: 20 years
Hospital or emergency department visits for any reason
Time frame: 10 and 20 year time points
change in eGFR over time
Time frame: 20 years
(MACE): non-fatal stroke, non-fatal myocardial infarction, cardiovascular death. Major risk factors: diabetes mellitus, dyslipidaemia, obesity, hypertension
Time frame: 20 years
bacterial, fungal or viral infection which necessitates hospital admission or medical attention
Time frame: 20 years
any cancer diagnosis following enrolment
Time frame: 20 years
acute kidney episodes (defined by KDIGO criteria), registry code or clinician assignment for group 1 or 2
Time frame: 10 years
time on dialysis (hours/days) and dialysis prescription (if available)
Western Sydney Local Health District
Other
Acronym: Genie
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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