Clinical Trials Logo

Clinical 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. 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.


Clinical Trial Description

n/a


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02206373
Study type Observational
Source National Taiwan University Hospital
Contact Fe-Lin L Wu, MSCP, PhD
Phone 886-2-23123456
Email flwu@ntu.edu.tw
Status Recruiting
Phase N/A
Start date January 2013
Completion date December 2015

See also
  Status Clinical Trial Phase
Terminated NCT05056727 - A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia Phase 3
Withdrawn NCT01655186 - A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus Phase 2
Completed NCT03481686 - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections N/A
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Enrolling by invitation NCT02237534 - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia Phase 4
Completed NCT02126293 - Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant Phase 3
Terminated NCT01533545 - Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients N/A
Completed NCT03280615 - Omega 3 Fatty Acids in Patients With Chronic Renal Disease Phase 3
Completed NCT04498156 - Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
Recruiting NCT04020328 - Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency Phase 4
Recruiting NCT06366529 - Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed NCT03836508 - Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis N/A
Completed NCT03250715 - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure N/A
Completed NCT03577249 - Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation Phase 2/Phase 3
Completed NCT01975818 - Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 Phase 2
Active, not recruiting NCT05766644 - App-based Education Program for CKD N/A
Active, not recruiting NCT02791880 - Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Recruiting NCT02947750 - Neurovascular Transduction During Exercise in Chronic Kidney Disease Phase 2
Terminated NCT02286258 - Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR) Phase 1/Phase 2