Renal Function DisorderNCT05112393
Development and Validation of Creatinine-Based Estimates of the Glomerular Filtration Rate Equation
An observational study of Renal Function Disorder, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Renal Function Disorder
- What is being tested?
- Development of new estimating Glomerular Filtration Rate (eGFR) equation and Validation of new estimating Glomerular Filtration Rate (eGFR) equation
- How many people
- 200 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Electronic Medical Records of patients with missing data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Function Disorder
- Being tested
- Development of new estimating Glomerular Filtration Rate (eGFR) equation, Validation of new estimating Glomerular Filtration Rate (eGFR) equation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of new estimating Glomerular Filtration Rate (eGFR) equationOther
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 of new estimating Glomerular Filtration Rate (eGFR) equationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Validation of new estimating Glomerular Filtration Rate (eGFR) equation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 1st December 2021 to 31st December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ina Ismiarti Shariffuddin, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112393
- Sponsor's protocol ID
- eGFR MY
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diego E, Castro P, Soy D, Poch E, Nicolas JM. Predictive performance of glomerular filtration rate estimation equations based on cystatin C versus serum creatinine values in critically ill patients. Am J Health Syst Pharm. 2016 Feb 15;73(4):206-15. doi: 10.2146/ajhp140852.
PubMed 26843497Bragadottir G, Redfors B, Ricksten SE. Assessing glomerular filtration rate (GFR) in critically ill patients with acute kidney injury--true GFR versus urinary creatinine clearance and estimating equations. Crit Care. 2013 Jun 15;17(3):R108. doi: 10.1186/cc12777.
PubMed 23767877Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
PubMed 1244564Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
PubMed 10075613Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
PubMed 19414839Rule AD, Teo BW. GFR estimation in Japan and China: what accounts for the difference? Am J Kidney Dis. 2009 Jun;53(6):932-5. doi: 10.1053/j.ajkd.2009.02.011. No abstract available.
PubMed 19463761Matsuo S, Yasuda Y, Imai E, Horio M. Current status of estimated glomerular filtration rate (eGFR) equations for Asians and an approach to create a common eGFR equation. Nephrology (Carlton). 2010 Jun;15 Suppl 2:45-8. doi: 10.1111/j.1440-1797.2010.01313.x.
PubMed 20586948Zelnick LR, Leca N, Young B, Bansal N. Association of the Estimated Glomerular Filtration Rate With vs Without a Coefficient for Race With Time to Eligibility for Kidney Transplant. JAMA Netw Open. 2021 Jan 4;4(1):e2034004. doi: 10.1001/jamanetworkopen.2020.34004.
PubMed 33443583Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1.
PubMed 19339088Jeong TD, Lee W, Yun YM, Chun S, Song J, Min WK. Development and validation of the Korean version of CKD-EPI equation to estimate glomerular filtration rate. Clin Biochem. 2016 Jun;49(9):713-719. doi: 10.1016/j.clinbiochem.2016.01.023. Epub 2016 Mar 9.
PubMed 26968101Praditpornsilpa K, Townamchai N, Chaiwatanarat T, Tiranathanagul K, Katawatin P, Susantitaphong P, Trakarnvanich T, Kanjanabuch T, Avihingsanon Y, Tungsanga K, Eiam-Ong S. The need for robust validation for MDRD-based glomerular filtration rate estimation in various CKD populations. Nephrol Dial Transplant. 2011 Sep;26(9):2780-5. doi: 10.1093/ndt/gfq815. Epub 2011 Feb 28.
PubMed 21357214Assadi M, Eftekhari M, Hozhabrosadati M, Saghari M, Ebrahimi A, Nabipour I, Abbasi MZ, Moshtaghi D, Abbaszadeh M, Assadi S. Comparison of methods for determination of glomerular filtration rate: low and high-dose Tc-99m-DTPA renography, predicted creatinine clearance method, and plasma sample method. Int Urol Nephrol. 2008;40(4):1059-65. doi: 10.1007/s11255-008-9446-4. Epub 2008 Aug 9.
PubMed 18690545Liu X, Qiu X, Shi C, Huang H, Huang J, Li M, Lou T. Modified glomerular filtration rate-estimating equations developed in asiatic population for chinese patients with type 2 diabetes. Int J Endocrinol. 2014;2014:521071. doi: 10.1155/2014/521071. Epub 2014 Mar 5.
PubMed 24734043Liao Y, Liao W, Liu J, Xu G, Zeng R. Assessment of the CKD-EPI equation to estimate glomerular filtration rate in adults from a Chinese CKD population. J Int Med Res. 2011;39(6):2273-80. doi: 10.1177/147323001103900624.
PubMed 22289543Ma YC, Zuo L, Zhang CL, Wang M, Wang RF, Wang HY. Comparison of 99mTc-DTPA renal dynamic imaging with modified MDRD equation for glomerular filtration rate estimation in Chinese patients in different stages of chronic kidney disease. Nephrol Dial Transplant. 2007 Feb;22(2):417-23. doi: 10.1093/ndt/gfl603. Epub 2006 Oct 19.
PubMed 17053082
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Creatinine-Based Estimates of the Glomerular Filtration Rate Equation From Chromium EDTA Imaging in the Multi-racial Malaysian Population
- ClinicalTrials.gov ID
- NCT05112393
- Acronym / sponsor ID
- eGFR MY
- Conditions
- Renal Function Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development Cohort | – | Other: Development of new estimating Glomerular Filtration Rate (eGFR) equationHalf 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 | – | Other: Validation of new estimating Glomerular Filtration Rate (eGFR) equationHalf 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Electronic Medical Records of patients with missing data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development of new estimating Glomerular Filtration Rate (eGFR) equationDevelopment Cohort: A new estimating Glomerular Filtration Rate(eGFR) equation will be developed by using a nonlinear regression model utilizing a generalized least squares algorithm. | Other | Development Cohort |
| Validation of new estimating Glomerular Filtration Rate (eGFR) equationValidation 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. | Other | Validation Cohort |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Background: PubMed 26843497Diego E, Castro P, Soy D, Poch E, Nicolas JM. Predictive performance of glomerular filtration rate estimation equations based on cystatin C versus serum creatinine values in critically ill patients. Am J Health Syst Pharm. 2016 Feb 15;73(4):206-15. doi: 10.2146/ajhp140852.
- Background: PubMed 23767877Bragadottir G, Redfors B, Ricksten SE. Assessing glomerular filtration rate (GFR) in critically ill patients with acute kidney injury--true GFR versus urinary creatinine clearance and estimating equations. Crit Care. 2013 Jun 15;17(3):R108. doi: 10.1186/cc12777.
- Background: PubMed 1244564Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
- Background: PubMed 10075613Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
- Background: PubMed 19414839Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
- Background: PubMed 19463761Rule AD, Teo BW. GFR estimation in Japan and China: what accounts for the difference? Am J Kidney Dis. 2009 Jun;53(6):932-5. doi: 10.1053/j.ajkd.2009.02.011. No abstract available.
- Background: PubMed 20586948Matsuo S, Yasuda Y, Imai E, Horio M. Current status of estimated glomerular filtration rate (eGFR) equations for Asians and an approach to create a common eGFR equation. Nephrology (Carlton). 2010 Jun;15 Suppl 2:45-8. doi: 10.1111/j.1440-1797.2010.01313.x.
- Background: PubMed 33443583Zelnick LR, Leca N, Young B, Bansal N. Association of the Estimated Glomerular Filtration Rate With vs Without a Coefficient for Race With Time to Eligibility for Kidney Transplant. JAMA Netw Open. 2021 Jan 4;4(1):e2034004. doi: 10.1001/jamanetworkopen.2020.34004.
- Background: PubMed 19339088Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1.
- Background: PubMed 26968101Jeong TD, Lee W, Yun YM, Chun S, Song J, Min WK. Development and validation of the Korean version of CKD-EPI equation to estimate glomerular filtration rate. Clin Biochem. 2016 Jun;49(9):713-719. doi: 10.1016/j.clinbiochem.2016.01.023. Epub 2016 Mar 9.
- Background: PubMed 21357214Praditpornsilpa K, Townamchai N, Chaiwatanarat T, Tiranathanagul K, Katawatin P, Susantitaphong P, Trakarnvanich T, Kanjanabuch T, Avihingsanon Y, Tungsanga K, Eiam-Ong S. The need for robust validation for MDRD-based glomerular filtration rate estimation in various CKD populations. Nephrol Dial Transplant. 2011 Sep;26(9):2780-5. doi: 10.1093/ndt/gfq815. Epub 2011 Feb 28.
- Background: PubMed 18690545Assadi M, Eftekhari M, Hozhabrosadati M, Saghari M, Ebrahimi A, Nabipour I, Abbasi MZ, Moshtaghi D, Abbaszadeh M, Assadi S. Comparison of methods for determination of glomerular filtration rate: low and high-dose Tc-99m-DTPA renography, predicted creatinine clearance method, and plasma sample method. Int Urol Nephrol. 2008;40(4):1059-65. doi: 10.1007/s11255-008-9446-4. Epub 2008 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ina Ismiarti Shariffuddin principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Function Disorder, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ina Ismiarti Shariffuddin (+10122353134, ismiarti@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New equation to estimate GFR that can be used specifically in Malaysian multiracial population (time frame: From 1st December 2021 to 31st December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05112393, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.