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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001371785

Enrollment

Registered

2022-10-26

Start date

2023-01-12

Completion date

2024-12-09

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

Interventions

empagliflozin 10mg tablet orally daily for 7 days, then increased to 25mg orally daily for 7 days followed by a 7 day wash out phase. The wash out phase is to observe how quickly kidney function returns to baseline following cessation of the drug. Participants will bring in drug container at end of each 7 day period to check complicance.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Now expanded to Individuals with non-diabetic stage 4 kidney disease with a stable eGFR between 30 and 15 ml/min/1.73m2 for the past 3 months. No change in medications over past 3 months. Not previously on empagliflozin.

Exclusion criteria

. Not able to give informed consent.

Outcome results