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

NCT06828562 | Enrolling By Invitation

• 1 other identifier: GENIE Study
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Kidney Disease

Keywords

kidney

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  20 years

Secondary Outcomes (8)

• Death

  20 years

• Hospital Admissions

  20 years

• estimated glomerular filtration rate slope

  10 and 20 year time points

• Cardiovascular event or major risk factors

  20 years

• Major infectious events

  20 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (4)

Royal Prince Alfred Hospital

Sydney, New South Wales, 2000, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Westmead Institute for Medical Research

Westmead, New South Wales, 2145, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and or residual biopsy (archive) tissue Optional - urine and faecal samples

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2050
• Last Updated: July 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)