Clinical trial NCT06828562: GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study
Official title: GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Disease
Keywords: kidney
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Australian participants - health and kidney disease (groups described earlier)

Brief summary: 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.

Detailed description: 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:

1. The susceptibility to developing acute kidney injury (AKI) and the severity of AKI.
2. The development of chronic kidney disease (CKD), and the complications of CKD
3. The progression to kidney failure (needing dialysis or transplant) and complications of kidney failure?
4. The risk of treatment failure (or resistance) to standard medical therapy for any of the above (1-4)?

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old at time of enrolment
* Able to provide consent
* Either have kidney disease at time of enrolment or not have kidney disease but has at least one risk factor for kidney disease (eg family history, hypertension, diabetes, smoking, stones, nephrotoxin use)
* Consent to longitudinal follow up at enrolment
* Consent to providing blood samples at enrolment

Exclusion Criteria:

* Unable or unwilling to provide consent
* life-expectancy less than 6-months
* received haematopoietic stem cell transplant in the past 5 years

Primary outcomes:
measure: Development of CKD
timeFrame: 20 years
measure: Progression of CKD
timeFrame: 20 years
measure: Removal from dialysis
timeFrame: 20 years
Secondary outcomes:
measure: Death
timeFrame: 20 years
measure: Hospital Admissions
timeFrame: 20 years
measure: estimated glomerular filtration rate slope
timeFrame: 10 and 20 year time points
measure: Cardiovascular event or major risk factors
timeFrame: 20 years
measure: Major infectious events
timeFrame: 20 years
measure: Malignancy
timeFrame: 20 years
measure: acute kidney episodes
timeFrame: 20 years
measure: Dialysis dose
timeFrame: 10 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Institute for Medical Research
state: New South Wales
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
References: