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

Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly

This study investigates renal functional reserve in elderly.

Study Overview

• Status: Recruiting
• Conditions: Renal Function Abnormal; Elder

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Kearkiat Praditpornsilpa
    • Contact: Kearkiat Praditpornsilpa, MD; Phone Number: 6602564251; Email: kearkiat@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elders age more than 60 years who are non-frail and has no limited life expectancy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of renal functional reserve per 12 months (mL/min)	Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion.	12 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Renal functional reserve, CKD progression, Elderly
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: IRB NO.527/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No