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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Dialysis Patients with Kidney Failure

Phase 1

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dialysis treatment history of ≥3 months

Be older than 18 years old

Must not have

Active treatment for malignancy

Unhealed lower extremity skin ulceration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-weeks

Summary

This trial studies if a diabetes med, empagliflozin, is safe & tolerated in dialysis patients. If successful, it could help reduce their risk of heart failure & death. #medicine

Who is the study for?

This trial is for adults with severe chronic kidney disease (ESKD) who have been on dialysis for at least 3 months, regardless of whether they have diabetes. It's not open to those with active cancer treatment, unhealed skin ulcers on the lower body, allergies to empagliflozin, pregnancy, type 1 diabetes, current IV antibiotic therapy for infections, a history of Fournier's gangrene or recent severe hypoglycemia.

What is being tested?

The study tests if empagliflozin is safe and can be tolerated by patients dependent on dialysis due to ESKD. Empagliflozin has helped prevent heart failure in diabetic and non-diabetic patients but hasn't been studied in those with advanced kidney disease undergoing dialysis.

What are the potential side effects?

Potential side effects may include risks associated with lowering blood sugar such as hypoglycemia (especially if diabetic), urinary tract infections due to increased glucose in urine, dehydration from increased urination which could affect blood pressure and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on dialysis for 3 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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I have an open sore on my leg that hasn't healed.

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I am currently receiving IV antibiotics for an infection.

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I have Type 1 diabetes.

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I have had Fournier's gangrene before.

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I have had diabetic ketoacidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Therapeutic procedure

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951

15%

Cardiac failure

Hypertension

Hypotension

Urinary tract infection

Renal impairment

Hyperkalaemia

Fall

Atrial fibrillation

Diabetes mellitus

Hyperuricaemia

Anaemia

Acute kidney injury

Pneumonia

COVID-19

Death

Acute myocardial infarction

Cardiac failure congestive

Basal cell carcinoma

Cardiac failure chronic

Cellulitis

Syncope

Chronic kidney disease

COVID-19 pneumonia

Ischaemic stroke

Coronary artery disease

Chronic obstructive pulmonary disease

Myocardial infarction

Sepsis

Transient ischaemic attack

Angina unstable

Cerebrovascular accident

Angina pectoris

Ventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Empagliflozin

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Empagliflozin 25mgExperimental Treatment1 Intervention

Empagliflozin 25 mg oral: Those randomized to 25 mg daily dose will be treated with 10 mg QD for the first 2 weeks before escalating the dose to 25 mg QD in week 3, based on tolerability. At the end of the dose-escalation phase (weeks 3-4), participants will continue the randomized assignment for additional 8 weeks (weeks 5-12, treatment phase), for a total of 12 weeks.

Group II: Empagliflozin 10mgExperimental Treatment1 Intervention

Empagliflozin10mg oral: Those randomized to 10 mg daily dose will be treated with 10 mg QD throughout the dose escalation and the treatment phase for a total of 12 weeks.

Group III: PlaceboPlacebo Group1 Intervention

Encapsulated placebo with an identical appearance to empagliflozin: Those randomized to placebo will be treated with an oral placebo QD throughout the dose escalation and the treatment phase for a total of 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

2017

Completed Phase 4

~181750

0 / 7Eligibility criteria met