Kidney DiseaseGenieNCT06828562
GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study
An observational study of Kidney Disease, run by Western Sydney Local Health District at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease
- How many people
- 500 participants
- Where
- 4 sitesAustralia
- Study dates
- 10 Feb 2025to 1 Jan 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Australian participants - health and kidney disease (groups described earlier)
Who may be able to join
- 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
Who cannot join
- Unable or unwilling to provide consent
- life-expectancy less than 6-months
- received haematopoietic stem cell transplant in the past 5 years
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Prince Alfred Hospital
Sydney, New South Wales, 2000
Westmead Hospital
Westmead, New South Wales, 2145
Westmead Institute for Medical Research
Westmead, New South Wales, 2145
About this 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.
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:
- 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)?
- Conditions
- Kidney Disease
- Keywords
- kidney
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 years
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
Measured: 20 years
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
Measured: 20 years
Secondary outcomes (8)
Death
death from any cause
Measured: 20 years
Hospital Admissions
Hospital or emergency department visits for any reason
Measured: 20 years
estimated glomerular filtration rate slope
change in eGFR over time
Measured: 10 and 20 year time points
Cardiovascular event or major risk factors
(MACE): non-fatal stroke, non-fatal myocardial infarction, cardiovascular death. Major risk factors: diabetes mellitus, dyslipidaemia, obesity, hypertension
Measured: 20 years
Major infectious events
bacterial, fungal or viral infection which necessitates hospital admission or medical attention
Measured: 20 years
Malignancy
any cancer diagnosis following enrolment
Measured: 20 years
acute kidney episodes
acute kidney episodes (defined by KDIGO criteria), registry code or clinician assignment for group 1 or 2
Measured: 20 years
Dialysis dose
time on dialysis (hours/days) and dialysis prescription (if available)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start10 Feb 2025
- Primary completion1 Jan 2040 (estimated)
- Study completion1 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Li, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828562
- Sponsor's protocol ID
- GENIE Study
- Acronym
- Genie
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential information and data sharing requires additional ethics submission or individual participant consent
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study
- ClinicalTrials.gov ID
- NCT06828562
- Acronym / sponsor ID
- Genie / GENIE Study
- Conditions
- Kidney Disease
- Keywords
- kidney
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 1 Jan 2040 (estimated)
- Study completion
- 1 Jan 2050 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Australian participants - health and kidney disease (groups described earlier)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unable or unwilling to provide consent
- life-expectancy less than 6-months
- received haematopoietic stem cell transplant in the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
8 secondary outcomes
Death
Time frame: 20 years
Hospital Admissions
Time frame: 20 years
estimated glomerular filtration rate slope
Time frame: 10 and 20 year time points
Cardiovascular event or major risk factors
Time frame: 20 years
Major infectious events
Time frame: 20 years
Malignancy
Time frame: 20 years
acute kidney episodes
Time frame: 20 years
Dialysis dose
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Confidential information and data sharing requires additional ethics submission or individual participant consent
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, run by Western Sydney Local Health District at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of CKD (time frame: 20 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.