Status:
COMPLETED
Global Kidney Patient Trials Network
Lead Sponsor:
The George Institute
Collaborating Sponsors:
Emerald Clinical Inc.
Conditions:
Kidney Diseases
Eligibility:
All Genders
2-80 years
Brief Summary
This is a prospective international multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease
Eligibility Criteria
Inclusion
- 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
- Willing and able to sign informed consent
- Willing to be approached about participation in interventional research studies
Exclusion
- 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)
Key Trial Info
Start Date :
May 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
5999 Patients enrolled
Trial Details
Trial ID
NCT04389827
Start Date
May 5 2020
End Date
October 31 2025
Last Update
December 15 2025
Active Locations (1)
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1
The George Institute
Sydney, New South Wales, Australia, 2031