Enrolling by invitation NCT06828562

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

— Observational Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Kidney Disease. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Australia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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:

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)?

Primary outcome measures

Development of CKD [Time frame: 20 years]
Progression of CKD [Time frame: 20 years]
Removal from dialysis [Time frame: 20 years]

Secondary outcome measures (8)

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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Cohort

Study locations

Australia · 4 centers

Royal Prince Alfred Hospital — Sydney
Westmead Hospital — Westmead
Westmead Institute for Medical Research — Westmead
Sir Charles Gairdner Hospital — Nedlands

Identifiers

NCT: NCT06828562 · GENIE Study

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗