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Trial record 1 of 1 for:    GKPTN
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Global Kidney Patient Trials Network

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389827
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
George Clinical Pty Ltd
Information provided by (Responsible Party):
The George Institute

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

Condition or disease
Kidney Diseases

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Global Kidney Patient Trials Network
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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


Outcome Measures
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Primary Outcome Measures :
  1. estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Collected Six-Monthly (minimum) ]
    Routine results

  2. Albuminuria [ Time Frame: Collected Six-Monthly (minimum) ]
    Routine results


Biospecimen Retention:   Samples With DNA
Blood and urine samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from units that provide a comprehensive nephrology service
Criteria

Inclusion Criteria:

  1. Documented diagnosis of primary kidney disease
  2. Regular visits (at least 6 monthly) with a physician at a participating site
  3. eGFR > 15 ml/min/1.73m2
  4. ≥ 2 years of age
  5. Willing and able to sign informed consent
  6. 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. Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389827


Contacts
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Contact: FanHan Hsu +61 2 8052 4511 gkptn@georgeinstitute.org.au
Contact: Enmoore Lin +61 2 8052 4511 gkptn@georgeinstitute.org.au

Locations
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Australia, New South Wales
The George Institute Recruiting
Sydney, New South Wales, Australia, 2042
Contact: Enmoore Lin    +61 2 8052 4511    gkptn@georgeinstitute.org.au   
Sponsors and Collaborators
The George Institute
George Clinical Pty Ltd
Investigators
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Principal Investigator: Hiddo Lambers Heerspink The George Institute
Principal Investigator: Sradha Kotwal The George Institute
More Information
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Additional Information:

Publications:

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Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT04389827    
Other Study ID Numbers: GKPTN2019
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The George Institute:
Chronic Kidney Disease
Diabetic Nephropathy
Hypertensive Kidney Disease
Glomerulonephritis (GN)
Focal Segmental Glomerulosclerosis (FSGS)
Membranous Nephropathy
 Minimal Change Disease
Immunoglobulin A Nephropathy (IgAN)
Glomerulonephritis not otherwise specified
GN
FSGS
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases