Global Kidney Patient Trials Network (GKPTN)

December 7, 2025 updated by: The George Institute
This is a prospective international multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • The George Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from units that provide a comprehensive nephrology service

Description

Inclusion Criteria:

  1. Documented diagnosis of primary kidney disease
  2. Regular visits (6-12 monthly) with a physician at a participating site that includes the monitoring of protein in urine and kidney function
  3. eGFR > 25 ml/min/1.73m2
  4. ≥ 2 to ≥ 80 years of age

  5. 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
  6. Willing and able to sign informed consent
  7. Willing to be approached about participation in interventional research studies

Exclusion Criteria:

  1. Life-expectancy of less than 6 months
  2. Currently receiving renal replacement therapy or planned to start in the next 6 months
  3. Planned transplant in the next 6 months
  4. Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Incident & Prevalent Patients
Incident and prevalent patients diagnosed with a kidney disease at participating centres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estimated Glomerular Filtration Rate (eGFR)
Time Frame: Collected Six-Monthly (minimum)
Routine results
Collected Six-Monthly (minimum)
Albuminuria
Time Frame: Collected Six-Monthly (minimum)
Routine results
Collected Six-Monthly (minimum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute

Collaborators

Emerald Clinical Inc.

Investigators

  • Principal Investigator: Hiddo Lambers Heerspink, The George Institute
  • Principal Investigator: Sradha Kotwal, The George Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2020

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GKPTN2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The current plan is that only aggregate data will be shared for research purposes. Individual participant data would only be reviewed in incidental findings and only be discussed with the participant in question.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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