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Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly

Sponsor
Chulalongkorn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05158959
Collaborator
(none)
100
Enrollment
1
Location
38.2
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigates renal functional reserve in elderly.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly
    Actual Study Start Date :
    Oct 24, 2019
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change of renal functional reserve per 12 months (mL/min) [12 months]

      Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient age > 60 years at screening

    • Patient willing to participate in the study and can provide inform consent

    • Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation

    Exclusion Criteria:

    • Patient active smoking

    • Patient have Charlson comorbidity index > .....

    • Patient active cancer

    • Patient contraindications for blood collection

    • Patients with a history of hypersensitivity to cimetidine or amino acid IV solution

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kearkiat Praditpornsilpa Bangkok Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kearkiat Praditpornsilpa, Professor of Medicine, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT05158959
    Other Study ID Numbers:
    • IRB NO.527/62
    First Posted:
    Dec 15, 2021
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Sep 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 Kearkiat Praditpornsilpa, Professor of Medicine, Chulalongkorn University
    Renal functional reserve, CKD progression, Elderly
    Additional relevant MeSH terms:
    Disease Progression

    Study Results

    No Results Posted as of Dec 15, 2021