NCT04389827
Completed
Not Applicable
Global Kidney Patient Trials Network
ConditionsKidney Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Diseases
- Sponsor
- The George Institute
- Enrollment
- 5999
- Locations
- 1
- Primary Endpoint
- Albuminuria
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This is a prospective international multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documented diagnosis of primary kidney disease
- •Regular visits (6-12 monthly) with a physician at a participating site that includes the monitoring of protein in urine and kidney function
- •eGFR \> 25 ml/min/1.73m2
- •≥ 2 to ≥ 80 years of age
- •One of the following laboratory urine parameters within 12 months of screening meeting the values of:
- •Urine Albumin-to-Creatinine Ratio (UACR) \> 200 mg/g OR
- •Protein-to-Creatinine Ratio (PCR) \> 300 mg/g OR
- •Albumin Excretion Rate (AER) \> 200 mg/day OR
- •24 hour Albumin Excretion \> 200 mg/day OR
- •24 hour Urine Protein Excretion \> 300 mg/day
Exclusion Criteria
- •Life-expectancy of less than 6 months
- •Currently receiving renal replacement therapy or planned to start in the next 6 months
- •Planned transplant in the next 6 months
- •Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)
Outcomes
Primary Outcomes
Albuminuria
Time Frame: Collected Six-Monthly (minimum)
Routine results
estimated Glomerular Filtration Rate (eGFR)
Time Frame: Collected Six-Monthly (minimum)
Routine results
Study Sites (1)
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