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OpenTrials
Completed

NCT Number: NCT04389827

Global Kidney Patient Trials Network

This is a prospective international multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease

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Key information

Conditions

Kidney Diseases Autoimmune Diseases Chronic Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Glomerulonephritis, Membranous Glomerulosclerosis, Focal Segmental Hypertensive Nephropathy Immune System Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrosis, Lipoid Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The George Institute

Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Willing and able to sign informed consent
  • Willing to be approached about participation in interventional research studies

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)

Treatment and study plan

Primary outcomes

  1. estimated Glomerular Filtration Rate (eGFR)

    Time frame: Collected Six-Monthly (minimum)

    Routine results

  2. Albuminuria

    Time frame: Collected Six-Monthly (minimum)

    Routine results

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Emerald Clinical Inc.

Registry information

Acronym: GKPTN

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 15, 2020
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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