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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | death from any cause | 20 years |
| Hospital Admissions | Hospital or emergency department visits for any reason | 20 years |
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Inclusion Criteria:
Exclusion Criteria:
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Australian participants - health and kidney disease (groups described earlier)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Sydney | New South Wales | 2000 | Australia | ||
| Westmead Hospital |
Confidential information and data sharing requires additional ethics submission or individual participant consent
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Blood and or residual biopsy (archive) tissue Optional - urine and faecal samples
| estimated glomerular filtration rate slope | change in eGFR over time | 10 and 20 year time points |
| Cardiovascular event or major risk factors | (MACE): non-fatal stroke, non-fatal myocardial infarction, cardiovascular death. Major risk factors: diabetes mellitus, dyslipidaemia, obesity, hypertension | 20 years |
| Major infectious events | bacterial, fungal or viral infection which necessitates hospital admission or medical attention | 20 years |
| Malignancy | any cancer diagnosis following enrolment | 20 years |
| acute kidney episodes | acute kidney episodes (defined by KDIGO criteria), registry code or clinician assignment for group 1 or 2 | 20 years |
| Dialysis dose | time on dialysis (hours/days) and dialysis prescription (if available) | 10 years |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| Westmead Institute for Medical Research | Westmead | New South Wales | 2145 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| D052801 | Male Urogenital Diseases |