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

NCT05112393 | Unknown

• 1 other identifier: eGFR MY
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Function Disorder

Outcome Measures

Primary Outcomes (1)

• New equation to estimate GFR that can be used specifically in Malaysian multiracial population

  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

Study Arms (2)

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

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

Interventions

Development of new estimating Glomerular Filtration Rate (eGFR) equation OTHER

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.

Development Cohort

Validation of new estimating Glomerular Filtration Rate (eGFR) equation OTHER

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.

Validation Cohort

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Electronic Medical Records of patients with missing data.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (20)

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• Jalalonmuhali M, Kok Peng N, Soo Kun L. Comparative Performance of Creatinine-Based Estimated Glomerular Filtration Rate Equations in the Malays: A Pilot Study in Tertiary Hospital in Malaysia. Int J Nephrol. 2017;2017:2901581. doi: 10.1155/2017/2901581. Epub 2017 Jun 18.

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• Jalalonmuhali M, Lim SK, Md Shah MN, Ng KP. MDRD vs. CKD-EPI in comparison to 51Chromium EDTA: a cross sectional study of Malaysian CKD cohort. BMC Nephrol. 2017 Dec 13;18(1):363. doi: 10.1186/s12882-017-0776-2.

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• Jalalonmuhali M, Elagel SMA, Tan MP, Lim SK, Ng KP. Estimating Renal Function in the Elderly Malaysian Patients Attending Medical Outpatient Clinic: A Comparison between Creatinine Based and Cystatin-C Based Equations. Int J Nephrol. 2018 May 13;2018:3081518. doi: 10.1155/2018/3081518. eCollection 2018.

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• Md Ralib A, Mohd Hanafiah FN, Abd Rashid I, Abd Rahim MS, Dzaharudin F, Mat Nor MB. Development and Validation of Creatinine-Based Estimates of the Glomerular Filtration Rate Equation from 99mTc-DTPA Imaging in the Malaysian Setting. Int J Nephrol. 2021 Sep 8;2021:3465472. doi: 10.1155/2021/3465472. eCollection 2021.

  PMID: 34540290 BACKGROUND

Study Officials

• Ina Ismiarti Shariffuddin

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ina Ismiarti Shariffuddin

CONTACT

+10122353134; ismiarti@ummc.edu.my

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: November 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

MY (1)