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Enrolling by Invitation

NCT Number: NCT06828562

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

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About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of CKD

    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

  2. Progression of CKD

    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

  3. Removal from dialysis

    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

Secondary outcomes

  1. Death

    Time frame: 20 years

    death from any cause

  2. Hospital Admissions

    Time frame: 20 years

    Hospital or emergency department visits for any reason

  3. estimated glomerular filtration rate slope

    Time frame: 10 and 20 year time points

    change in eGFR over time

  4. Cardiovascular event or major risk factors

    Time frame: 20 years

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

  5. Major infectious events

    Time frame: 20 years

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

  6. Malignancy

    Time frame: 20 years

    any cancer diagnosis following enrolment

  7. acute kidney episodes

    Time frame: 20 years

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

  8. Dialysis dose

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: Genie

Important dates

Study start
2025
Primary completion
2040
Study completion
2050
First posted
Feb 14, 2025
Registry last updated
Jul 17, 2025

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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