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

Development and Validation of Creatinine-Based Estimates of the Glomerular Filtration Rate Equation From Chromium EDTA Imaging in the Multi-racial Malaysian Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05112393
Enrollment
200
Registered
2021-11-08
Start date
2021-11-30
Completion date
2022-12-31
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Function Disorder

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.

Interventions

OTHERDevelopment of new estimating Glomerular Filtration Rate (eGFR) equation

Development Cohort: A new estimating Glomerular Filtration Rate(eGFR) equation will be developed by using a nonlinear regression model utilizing a generalized least squares algorithm.

OTHERValidation of new estimating Glomerular Filtration Rate (eGFR) equation

Validation Cohort: Internal validation will be performed by comparing bias, precision and accuracy of the new equations and the other established equations to the measured GFR.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

Malaysia

Contacts

Primary ContactIna Ismiarti Shariffuddin
ismiarti@ummc.edu.my+10122353134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026