ANZCTR12622001371785

Empagliflozin in stage 4 non-diabetic kidney disease

Sodium glucose co-transporter 2 inhibitors (SGLT2-I) effect on glucose and sodium clearance in those with stage 4 non-diabetic chronic kidney disease.
University of Otago·Phase 3/4·Australian New Zealand Clinical Trials Registry·drugRecruiting
Study focus
Disease/Condition
Chronic kidney disease
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Otago
Funder
Otago Medical Research Foundation
Location
New Zealand
Timeline & enrollment
Phase
Phase 3/4
Start date
Jan 12, 2023
End date
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
Chronic kidney diseaseChronic kidney disease, unspecifiedChronic kidney disease, stage 1Chronic kidney disease, stage 4Chronic kidney disease, stage 2
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12622001371785
Type
Non-Device Trial
About this record

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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