Estimated Creatinine ClearanceNCT02040181
Establishment of a Creatinine Clearance Estimation Equation and Daily Creatinine Excretion Reference Table for Taiwanese
An observational study of Estimated Creatinine Clearance, run by National Taiwan University Hospital.
Trial summary
It's important to dose according to renal function in who has impaired kidney function. There are two common methods estimating renal function: one is creatinine clearance estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD)… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Estimated Creatinine Clearance
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jul 2014
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients or inpatients of National Taiwan University Hospital who had 24 hour urine creatinine collections during 2010/1/1 to 2012/12/31.
Who may be able to join
- age above or equal to 20 year-old adults
- had 24 hour urine creatinine collection
Who cannot join
- lack of at least one :sex, diagnosis, age,weight, height
- serum creatinine beyond linear test range
- with extreme weight or height
- with acute kidney injury or specific diagnosis
- with extremities of daily urine creatinine excretion
About this study
It's important to dose according to renal function in who has impaired kidney function. There are two common methods estimating renal function: one is creatinine clearance estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD) equation.
The previous study (not published) showed that CG underestimated 24 hour measured urine creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to establish a estimated creatinine clearance equation fitting in Taiwanese.
Besides, there are lots of studies discussing difference between CG and MDRD. We have found that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis which characteristics of patients the difference are largest or smallest.
- Conditions
- Estimated Creatinine Clearance
- Keywords
- renal function, creatinine clearance
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of determination of estimated creatinine clearance equation
Compare new estimated creatinine clearance equation for Taiwanese with Cockcroft-Gault equation
Measured: 3 years
Secondary outcomes (1)
Differences of daily urine creatinine excretion between Caucasian and Taiwanese
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estimated Creatinine ClearanceStudies 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
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fe-Lin Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040181
- Sponsor's protocol ID
- 201311047RINC
- Status last verified
- Jul 2014
- First submitted
- 22 Dec 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Creatinine Clearance Estimation Equation and Daily Creatinine Excretion Reference Table for Taiwanese
- ClinicalTrials.gov ID
- NCT02040181
- Acronym / sponsor ID
- 201311047RINC
- Conditions
- Estimated Creatinine Clearance
- Keywords
- renal function, creatinine clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Jan 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.
It's important to dose according to renal function in who has impaired kidney function. There are two common methods estimating renal function: one is creatinine clearance estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD) equation.
The previous study (not published) showed that CG underestimated 24 hour measured urine creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to establish a estimated creatinine clearance equation fitting in Taiwanese.
Besides, there are lots of studies discussing difference between CG and MDRD. We have found that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis which characteristics of patients the difference are largest or smallest.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients or inpatients of National Taiwan University Hospital who had 24 hour urine creatinine collections during 2010/1/1 to 2012/12/31.
Key inclusion criteria (2 listed)
- age above or equal to 20 year-old adults
- had 24 hour urine creatinine collection
Key exclusion criteria (5 listed)
- lack of at least one :sex, diagnosis, age,weight, height
- serum creatinine beyond linear test range
- with extreme weight or height
- with acute kidney injury or specific diagnosis
- with extremities of daily urine creatinine excretion
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
Coefficient of determination of estimated creatinine clearance equation
Time frame: 3 years
Compare new estimated creatinine clearance equation for Taiwanese with Cockcroft-Gault equation
1 secondary outcome
Differences of daily urine creatinine excretion between Caucasian and Taiwanese
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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.
Fe-Lin Lin principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Estimated Creatinine Clearance, run by National Taiwan University Hospital.
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 5 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: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of determination of estimated creatinine clearance equation (time frame: 3 years). 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 30 Jul 2014.