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Safety and Efficacy of Empagliflozin in Hemodialysis - Trial NCT05786443

Access comprehensive clinical trial information for NCT05786443 through Pure Global AI's free database. This Phase 2 trial is sponsored by NYU Langone Health and is currently Not yet recruiting. The study focuses on End Stage Renal Disease. Target enrollment is 60 participants.

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NCT05786443
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05786443
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Safety and Efficacy of Empagliflozin in Hemodialysis
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Empagliflozin Among Patients Initiating Hemodialysis for the Treatment of End-Stage Kidney Disease

Study Focus

End Stage Renal Disease

Empagliflozin 10 MG

Interventional

drug

Sponsor & Location

NYU Langone Health

Boston,New York, United States of America

Timeline & Enrollment

Phase 2

Jun 01, 2023

Dec 30, 2025

60 participants

Primary Outcome

Change in Extracellular Volume from Baseline to 12 Weeks,Change in Intracellular Volume from Baseline to 12 Weeks,Change in Total Body Water from Baseline to 12 Weeks,Change in 24-Hour Urine Volume from Baseline to 12 Weeks

Summary

A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to
 assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo
 among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.

ICD-10 Classifications

Chronic kidney disease, stage 1
Chronic kidney disease, stage 5
Chronic kidney disease, stage 2
Chronic kidney disease, stage 3
Chronic kidney disease, stage 4

Data Source

ClinicalTrials.gov

NCT05786443

Non-Device Trial