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Enrolling by invitationNCT06828562GenieUpdated Oct 14, 2026

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

An observational study in Kidney Disease, sponsored by Western Sydney Local Health District. Enrolling by invitation at 4 sites in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Western Sydney Local Health District · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)?
02

Conditions studied

  • Kidney Disease

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Keywords

  • kidney
03

In context

Kidney Diseases

969 studies on the registry are indexed under Kidney Diseases; 183 are open to participants now.

This study's planned enrollment of 500 is above the median of 245 across 277 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Australian participants - health and kidney disease (groups described earlier)

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.

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

Exclusion Criteria:

  • Unable or unwilling to provide consent
  • life-expectancy less than 6-months
  • received haematopoietic stem cell transplant in the past 5 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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)

  • 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.

  • Group 3 - Participants with kidney failure and are on dialysis

    Patients established on peritoneal dialysis or haemodialysis for at least 3 months

06

What researchers measure

Primary outcomes

  1. Development of CKD

    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

  2. Progression of CKD

    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

  3. Removal from dialysis

    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

Secondary outcomes

  1. Death

    death from any cause

    Time frame: 20 years

  2. Hospital Admissions

    Hospital or emergency department visits for any reason

    Time frame: 20 years

  3. estimated glomerular filtration rate slope

    change in eGFR over time

    Time frame: 10 and 20 year time points

  4. Cardiovascular event or major risk factors

    (MACE): non-fatal stroke, non-fatal myocardial infarction, cardiovascular death. Major risk factors: diabetes mellitus, dyslipidaemia, obesity, hypertension

    Time frame: 20 years

  5. Major infectious events

    bacterial, fungal or viral infection which necessitates hospital admission or medical attention

    Time frame: 20 years

  6. Malignancy

    any cancer diagnosis following enrolment

    Time frame: 20 years

  7. acute kidney episodes

    acute kidney episodes (defined by KDIGO criteria), registry code or clinician assignment for group 1 or 2

    Time frame: 20 years

  8. Dialysis dose

    time on dialysis (hours/days) and dialysis prescription (if available)

    Time frame: 10 years

07

Study locations

4 sites
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References and documents

Individual participant data

Plan to share: No — Confidential information and data sharing requires additional ethics submission or individual participant consent

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06828562
Lead sponsor
Western Sydney Local Health District
Responsible party
Jennifer Li (Principal Investigator, Western Sydney Local Health District) — Principal investigator
First posted
Feb 14, 2025
Start date
Feb 10, 2025
Primary completion
Jan 1, 2040 (estimated)
Completion
Jan 1, 2050 (estimated)
Last update
Oct 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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