Creatinine Clearance Quantitative Trait LocusNCT02206373
How to Dose a Patient According to Renal Function? Glomerular Filtration Rate (GFR) or Creatinine Clearance (ClCr)
An observational study of Creatinine Clearance Quantitative Trait Locus and Renal Insufficiency, Chronic, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there are many factors that may affect the measurement of serum creatinine, it is a well-accepted marker for renal function assessment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Creatinine Clearance Quantitative Trait Locus, Renal Insufficiency, Chronic
- How many people
- 60,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 2012.01.01~2012.12.31 adult patients with serum creatinine test result in NTUH
Who may be able to join
- adult patients with serum creatinine test result
Who cannot join
- unstable renal function, hemodialysis, cachexia, pregnancy, severe burn, muscle atrophy, severe trauma, amputation, liver failure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Tapei, 10051
Fe-Lin L Wu, MSCP, PhD, 886-2-23123456 ext. 88389
About this study
Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there are many factors that may affect the measurement of serum creatinine, it is a well-accepted marker for renal function assessment. The creatinine clearance (ClCr) estimated by Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in CKD staging. ClCr and eGFR not only have different units, but the results of estimation from the two varied among races and individuals. Since 2010, US Food and Drug Administration required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal insufficient patients during pharmacokinetic studies. Because most drugs are excreted through kidney, an understanding on the relationship between ClCr and eGFR is important to dose safely and effectively. Furthermore, identifying the factors that may influence the difference between ClCr and eGFR can provide in-depth consideration during clinical renal function assessment.
Purpose： The purpose of this study is to analyze the correlation between different ClCr and eGFR equations in order to provide better renal dose. We also want to find the factors that may cause the differences between them.
Methods： This study will conduct literature review to understand study population during the development of different ClCr and eGFR equations, as well as their scope of application. National Taiwan University Hospital electronic patient database will be used to analyze the correlation between ClCr and eGFR and to identify factors that may influence the difference between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine collection with calculated renal function will be used to verify the applicability of these equations (including a ClCr equation developed by our institute) in Taiwanese. Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal function while dosing a patient.
- Keywords
- creatinine, glomerular filtration rate, renal insufficiency, chronic
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between estimated glomerular filtration rate and creatinine clearance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Creatinine Clearance Quantitative Trait LocusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206373
- Sponsor's protocol ID
- 201301031RINC
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2014
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Dose a Patient According to Renal Function? Glomerular Filtration Rate (GFR) or Creatinine Clearance (ClCr)
- ClinicalTrials.gov ID
- NCT02206373
- Acronym / sponsor ID
- 201301031RINC
- Keywords
- creatinine, glomerular filtration rate, renal insufficiency, chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- 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.
Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there are many factors that may affect the measurement of serum creatinine, it is a well-accepted marker for renal function assessment. The creatinine clearance (ClCr) estimated by Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in CKD staging. ClCr and eGFR not only have different units, but the results of estimation from the two varied among races and individuals. Since 2010, US Food and Drug Administration required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal insufficient patients during pharmacokinetic studies. Because most drugs are excreted through kidney, an understanding on the relationship between ClCr and eGFR is important to dose safely and effectively. Furthermore, identifying the factors that may influence the difference between ClCr and eGFR can provide in-depth consideration during clinical renal function assessment.
Purpose： The purpose of this study is to analyze the correlation between different ClCr and eGFR equations in order to provide better renal dose. We also want to find the factors that may cause the differences between them.
Methods： This study will conduct literature review to understand study population during the development of different ClCr and eGFR equations, as well as their scope of application. National Taiwan University Hospital electronic patient database will be used to analyze the correlation between ClCr and eGFR and to identify factors that may influence the difference between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine collection with calculated renal function will be used to verify the applicability of these equations (including a ClCr equation developed by our institute) in Taiwanese. Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal function while dosing a patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 2012.01.01~2012.12.31 adult patients with serum creatinine test result in NTUH
Key inclusion criteria (1 listed)
- adult patients with serum creatinine test result
Key exclusion criteria (1 listed)
- unstable renal function, hemodialysis, cachexia, pregnancy, severe burn, muscle atrophy, severe trauma, amputation, liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference between estimated glomerular filtration rate and creatinine clearance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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.
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 Creatinine Clearance Quantitative Trait Locus and Renal Insufficiency, Chronic, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 11 Aug 2015. 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 Taiwan. 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 Fe-Lin L Wu, MSCP, PhD (886-2-23123456 ext. 88389, flwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between estimated glomerular filtration rate and creatinine clearance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2015.