Development and Validation of Creatinine-Based Estimates of the Glomerular Filtration Rate Equation

• Conditions: Renal Function Disorder
• Interventions: Other: Development of new estimating Glomerular Filtration Rate (eGFR) equation; Other: Validation of new estimating Glomerular Filtration Rate (eGFR) equation

• Registration Number: NCT05112393
• Lead Sponsor: University of Malaya

Brief Summary

This study aim to recruit all Electronic Medical Record of patients who underwent for 51chromium ethylenediamine tetra acetic acid (51Cr-EDTA) imaging at the Nuclear Medicine Centre, University Malaya Medical Centre from September 2016 to September 2021. The data that collected will be analyzed to develop and validate a new equation to estimate Glomerular Filtration Rate that specifically for Malaysian multiracial population.

Detailed Description

List of patients who underwent for 51Cr EDTA imaging at the Nuclear Medicine Centre, University Malaya Medical Centre from September 2016 to September 2021 will be obtained from relevant department. All patient's Electronic Medical Record (EMR) will be evaluated for recruitment into the study.

Demographics data of the patients that will be collected include age, gender, height, weight, and ethnicity. The clinical data that will be collected include CKD aetiology, background comorbidities, and vitals sign and laboratory data includes the renal function test. The 51Cr- EDTA readings were also recorded.

If there are multiple measurements of scans performed, the latest 51Cr-EDTA taken. The renal function test must be within three months of when the 51Cr-EDTA imaging was conducted.

Patients will be randomized into a development and validation cohort using a random number generated in Microsoft Excel. In the development cohort, a new equation will be developed using a nonlinear regression model utilizing a generalized least squares algorithm. Internal validation will be performed in the validation cohort, by comparing the bias, precision, and accuracy of the new equations and the other established equations to the measured GFR.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study Start: 2021-11
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Electronic Medical Records of patient scheduled for 51Cr EDTA imaging at the Nuclear Medicine Centre, University Malaya Medical Centre from September 2016 to September 2021
• Age 16-year-old and above

Exclusion Criteria

• Electronic Medical Records of patients with missing data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Development Cohort	Development of new estimating Glomerular Filtration Rate (eGFR) equation	Half of the data will be randomized into development cohort by using a random number generated in Microsoft Excel. This cohort aim to develop a new estimating Glomerular Filtration Rate (eGFR) equation that produce accurate eGFR specifically in Malaysian multiracial population.
Validation Cohort	Validation of new estimating Glomerular Filtration Rate (eGFR) equation	Half of the data will be randomized into development cohort by using a random number generated in Microsoft Excel. This cohort aim to validate the newly developed estimating Glomerular Filtration Rate (eGFR) equation.

Primary Outcome Measures

Name	Time	Method
New equation to estimate GFR that can be used specifically in Malaysian multiracial population	From 1st December 2021 to 31st December 2022	New equation that has its own ethnic coefficient that can produce accurate result in Malaysia multiracial population

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia