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

Western Sydney Local Health District

Status: Invitation-only

Conditions: Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06828562

GENIE Study

Details and patient eligibility

About

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.

Full 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)?

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Group 1 - Healthy participants (without established kidney disease)

Description:

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)

Description:

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

Description:

Patients established on peritoneal dialysis or haemodialysis for at least 3 months