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CKPTN: China Kidney Patient Trials Network

Sponsor
George (Beijing) Clinical Research Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05036850
Collaborator
(none)
1,200
Enrollment
1
Location
113.1
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    China Kidney Patient Trials Network
    Actual Study Start Date :
    Sep 27, 2021
    Anticipated Primary Completion Date :
    Sep 15, 2026
    Anticipated Study Completion Date :
    Feb 28, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    Incident and Prevalent Patients

    Incident and prevalent patients diagnosed with a kidney disease at participating centres

    Outcome Measures

    Primary Outcome Measures

    1. eGFR (estimated Glomerular Filtration Rate) [Collected six monthly, up to 5 years]

      Routine results

    2. Albuminuria [Collected six monthly, up to 5 years]

      Routine results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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/1.73 m2

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 George Clinical (Beijing) Beijing Beijing China 100125

    Sponsors and Collaborators

    • George (Beijing) Clinical Research Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    George (Beijing) Clinical Research Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT05036850
    Other Study ID Numbers:
    • CKPTN2019
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by George (Beijing) Clinical Research Co. Ltd.
    Chronic Kidney Disease
    Diabetic Nephropathy
    Hypertensive Kidney Disease
    Glomerulonephritis
    GN
    Focal Segmental Glomerulosclerosis
    FSGS
    Membranous Nephropathy
    Minimal Change Disease
    IgA Nephropathy
    Glomerulonephritis not otherwise specified
    Additional relevant MeSH terms:
    Kidney Diseases

    Study Results

    No Results Posted as of Dec 17, 2021