Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02206373
Status:
UNKNOWN
Last Update Posted:
2015-08-11
First Post:
2014-07-28
Brief Title:
How to Dose a Patient According to Renal Function Glomerular Filtration Rate GFR or Creatinine Clearance ClCr
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
How to Dose a Patient According to Renal Function Glomerular Filtration Rate GFR or Creatinine Clearance ClCr
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None