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

Elder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158959
• Other study ID #: IRB NO.527/62
• Status: Recruiting
• Start date: October 24, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study investigates renal functional reserve in elderly.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Renal Function Abnormal

Locations

Country	Name	City	State
Thailand	Kearkiat Praditpornsilpa	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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