GENomic Predictors in a Multi-Ethnic Population with Kidney Disease Study

Active, not recruiting

• Conditions: Kidney Disease

• Registration Number: NCT06828562
• Lead Sponsor: Western Sydney Local Health District

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.

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)?

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-10
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2040-01-01
• Study Completion: 2050-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of CKD	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	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	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 Outcome Measures

Name	Time	Method
Death	20 years	death from any cause
Hospital Admissions	20 years	Hospital or emergency department visits for any reason
estimated glomerular filtration rate slope	10 and 20 year time points	change in eGFR over time
Cardiovascular event or major risk factors	20 years	(MACE): non-fatal stroke, non-fatal myocardial infarction, cardiovascular death. Major risk factors: diabetes mellitus, dyslipidaemia, obesity, hypertension
Major infectious events	20 years	bacterial, fungal or viral infection which necessitates hospital admission or medical attention
Malignancy	20 years	any cancer diagnosis following enrolment
acute kidney episodes	20 years	acute kidney episodes (defined by KDIGO criteria), registry code or clinician assignment for group 1 or 2
Dialysis dose	10 years	time on dialysis (hours/days) and dialysis prescription (if available)

Trial Locations

Locations (4)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Westmead Institute for Medical Research; 🇦🇺 Westmead, New South Wales, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia