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Clinical Trials/NCT04389827
NCT04389827
Completed
Not Applicable

Global Kidney Patient Trials Network

The George Institute1 site in 1 country5,999 target enrollmentMay 5, 2020
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

Registry
clinicaltrials.gov
Start Date
May 5, 2020
End Date
October 31, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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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