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

October 27, 2021 updated by: University of Malaya

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Development Cohort
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.
Other: Development 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.
Validation Cohort
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.
Other: Validation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New equation to estimate GFR that can be used specifically in Malaysian multiracial population
Time Frame: 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
From 1st December 2021 to 31st December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Ina Ismiarti Shariffuddin, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • eGFR MY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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