GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study

NCT ID: NCT06828562

Last Updated: 2025-07-17

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-10

Study Completion Date

2050-01-01

Brief Summary

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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

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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)?

Conditions

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Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western Sydney Local Health District

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Westmead Institute for Medical Research

Westmead, New South Wales, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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GENIE Study

Identifier Type: -

Identifier Source: org_study_id

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