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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06828562




Registration number
NCT06828562
Ethics application status
Date submitted
10/02/2025
Date registered
14/02/2025
Date last updated
19/02/2025

Titles & IDs
Public title
GENomic Predictors in a Multi-Ethnic Population with Kidney Disease Study
Scientific title
GENomic Predictors in a Multi-Ethnic Population with Kidney Disease Study
Secondary ID [1] 0 0
GENIE Study
Universal Trial Number (UTN)
Trial acronym
Genie
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development of CKD
Timepoint [1] 0 0
20 years
Primary outcome [2] 0 0
Progression of CKD
Timepoint [2] 0 0
20 years
Primary outcome [3] 0 0
Removal from dialysis
Timepoint [3] 0 0
20 years
Secondary outcome [1] 0 0
Death
Timepoint [1] 0 0
20 years
Secondary outcome [2] 0 0
Hospital Admissions
Timepoint [2] 0 0
20 years
Secondary outcome [3] 0 0
estimated glomerular filtration rate slope
Timepoint [3] 0 0
10 and 20 year time points
Secondary outcome [4] 0 0
Cardiovascular event or major risk factors
Timepoint [4] 0 0
20 years
Secondary outcome [5] 0 0
Major infectious events
Timepoint [5] 0 0
20 years
Secondary outcome [6] 0 0
Malignancy
Timepoint [6] 0 0
20 years
Secondary outcome [7] 0 0
acute kidney episodes
Timepoint [7] 0 0
20 years
Secondary outcome [8] 0 0
Dialysis dose
Timepoint [8] 0 0
10 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unable or unwilling to provide consent
* life-expectancy less than 6-months
* received haematopoietic stem cell transplant in the past 5 years

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2050
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Westmead Institute for Medical Research - Westmead
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06828562
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06828562