Phase 3 N=6,609 Randomized Double-blind Treatment

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT03594110 ↗

Enrolled (actual)

6,609

Serious AEs

34.1%

Results posted

Jul 2023

Primary outcome: Primary: Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') — 8.96; 6.85 patients with events/100 pt-yrs at risk — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Empagliflozin (Drug); Matching placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')	8.96; 6.85	<0.0001 sig
PRIMARY Overall Study: Time to the First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')	9.99; 8.36	—
SECONDARY Key Secondary Endpoint: Interventional Part - Time to First Hospitalization for Heart Failure ('as Adjudicated') or Cardiovascular Death ('as Adjudicated')	2.39; 2.04	0.1363
SECONDARY Key Secondary Endpoint: Interventional Part - Time to Occurrences of All-cause Hospitalizations (First and Recurrent Combined)	1895; 1612	0.0022 sig
SECONDARY Key Secondary Endpoint: Interventional Part - Time to Death From Any Cause ('as Adjudicated')	2.59; 2.29	0.2122
SECONDARY Interventional Part: Time to First Occurrence of Kidney Disease Progression	8.09; 6.09	<0.0001 sig
SECONDARY Interventional Part: Time to Cardiovascular Death ('as Adjudicated')	1.08; 0.91	0.2932
SECONDARY Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)	3.45; 2.55	0.0017 sig
SECONDARY Overall Study: Time to First Occurrence of Kidney Disease Progression	8.95; 7.52	—
SECONDARY Overall Study: Time to First Occurrence of Death From Any Cause or ESKD	6.08; 5.13	—
SECONDARY Overall Study: Time to First Occurrence of ESKD	3.49; 2.72	—
SECONDARY Body Composition Measurement Sub-study: Mean Absolute Fluid Overload, Averaged Over Time	0.34; 0.10	< 0.001 sig
SECONDARY Magnetic Resonance Imaging Sub-study: Kidney Cortical T1 Mapping as Measured by Modified Look-Locker Inversion Recovery (MOLLI) at 18 Months	1634; 1622	0.41

Summary

The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).

Eligibility Criteria

Inclusion Criteria

Age ≥18 years or at "full age" as required by local regulation
Evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of Screening Visit
CKD-EPI eGFR ≥20 to 60 mL/min/1.73m2 at Screening
Receiving combined ACEi and ARB treatment
Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant
Polycystic kidney disease
Previous or scheduled bariatric surgery
Ketoacidosis in the past 5 years
Symptomatic hypotension, or systolic blood pressure 180 mmHg at Screening
ALT or AST >3x ULN at Screening
Hypersensitivity to empagliflozin or other SGLT-2 inhibitor
Any intravenous immunosuppression therapy in last 3 months; or anyone currently on >45 mg prednisolone (or equivalent)
Use of an investigational medicinal product in the 30 days prior to Screening visit
Known to be poorly compliant with clinic visits or prescribed medication
Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception
Type 1 diabetes mellitus

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03594110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.