Kidney Disease
Conditions
Keywords
kidney
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)?
Interventions
None listed
Sponsors
Western Sydney Local Health District
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Death | 20 years | death from any cause |
| 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) |
| Malignancy | 20 years | any cancer diagnosis following enrolment |
| 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 |
Countries
Australia
Outcome results
None listed