Empagliflozin in stage 4 non-diabetic kidney disease - Trial ANZCTR12622001371785
Access comprehensive clinical trial information for ANZCTR12622001371785 through Pure Global AI's free database. This Phase 3/4 trial is sponsored by University of Otago and is currently Recruiting. The study focuses on Chronic kidney disease.
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Study Focus
Sponsor & Location
University of Otago
Otago Medical Research Foundation
Timeline & Enrollment
Phase 3/4
Jan 12, 2023
Nov 30, 2023
Primary Outcome
Empagliflozin pharmacokinetics will be characterised using standard non-compartmental methods as well as a non-linear mixed effects methodology. Pharmacokinetic parameters including maximum and minimal plasma concentrations, volume of distribution, half-life, area-under the plasma concentration time curve (for the 24 hour profile), total apparent plasma clearance, free ad bound clearance, and renal clearance will be estimated as well as measured using urinary excretion and compared to those expected for individuals with CKD3 and 2.
Summary
This pilot study aims to have a better understanding of the pharmacokinetics and pharmacodynamics of two oral doses of empagliflozin and the drug's effect on glucose and sodium clearance as well as kidney function, blood pressure and cardiac function as assessed by echocardiography in those with among Stage 4 non diabetic chronic kidney disease (CKD).
ICD-10 Classifications
Data Source
Australian New Zealand Clinical Trials Registry
ANZCTR12622001371785
Non-Device Trial