GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study
NCT ID: NCT06828562
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
500 participants
OBSERVATIONAL
2025-02-10
2050-01-01
Brief Summary
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Detailed Description
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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)?
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 - Healthy participants (without established kidney disease)
eGFR \> 60ml/min/1.73m2, UACR \< 3 mg/mmol (or UPCR \< 10 mg/mmol)
Has risk factors for kidney disease, including any of the following:
Family history of kidney disease (CKD, dialysis or transplant) Any history of acute kidney injury or eGFR decline from baseline Established diabetes, hypertension, stroke, heart disease or heart failure Current or ex-smoker, overweight (BMI \> 25) or obesity (BMI \> 30)
No interventions assigned to this group
Group 2 - Participants with established chronic kidney disease (CKD)
eGFR ≤ 60ml/min/1.73m2 (over minimum 3-month period), or UACR \> 30mg/mmol (or PCR \> 100mg/mmol). CKD can be from any cause/aetiology.
No interventions assigned to this group
Group 3 - Participants with kidney failure and are on dialysis
Patients established on peritoneal dialysis or haemodialysis for at least 3 months
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* life-expectancy less than 6-months
* received haematopoietic stem cell transplant in the past 5 years
18 Years
ALL
Yes
Sponsors
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Western Sydney Local Health District
OTHER
Responsible Party
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Jennifer Li
Principal Investigator
Locations
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Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Westmead Institute for Medical Research
Westmead, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Countries
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Other Identifiers
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GENIE Study
Identifier Type: -
Identifier Source: org_study_id
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