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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Kidney Failure

Phase 1 & 2

Recruiting

Led By Yoshitsugu Obi, MD, PhD

Research Sponsored by University of Mississippi Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of end-stage kidney disease requiring dialysis

diagnosis of end-stage kidney disease requiring dialysis

Must not have

Known allergy or hypersensitivity to any SGLT2 inhibitors

History of ketoacidosis during the last 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of empagliflozin in dialysis patients; results may lead to a larger clinical trial to explore the potential heart benefits of empagliflozin.

Who is the study for?

This trial is for adults over 18 with end-stage kidney disease on dialysis. They must be able to consent and not have had recent major surgery, active cancer, heart or liver transplants, severe low blood pressure before dialysis, certain infections or urinary issues in the past year, advanced heart failure needing devices or drugs to help the heart work, liver cirrhosis, a history of ketoacidosis within a year, known allergies to SGLT2 inhibitors like empagliflozin.

What is being tested?

The study tests if empagliflozin is safe for patients on dialysis due to kidney failure. It explores two dosing methods: one takes 25 mg after each hemodialysis session (thrice-weekly), and another takes 10 mg daily. Participants will also receive standard medical care during the three-month treatment period plus follow-up for an additional month.

What are the potential side effects?

Potential side effects of empagliflozin may include urinary tract infections due to increased sugar in urine which bacteria feed on; dehydration because it causes more urination; low blood pressure; and ketoacidosis—a serious condition where too much acid builds up in the blood.

Eligibility Criteria

Inclusion Criteria

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

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I am on dialysis for end-stage kidney disease.

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I am on dialysis for end-stage kidney disease.

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I am 18 years old or older.

Exclusion Criteria

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

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I am allergic to SGLT2 inhibitors.

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I have had ketoacidosis in the past year.

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I have had 2 or more UTIs in the last year.

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I currently have active cancer.

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I need a device or medication to help my heart pump.

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I have received a heart or liver transplant.

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I have had issues with not being able to urinate or blockages in my urinary tract.

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I have liver cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis

Dropout rate

Length of time on continuous glucose monitoring

+4 more

Secondary study objectives

% Time of active CGM

Average glucose

Changes Estimated glomerular filtration rate (GFR) from baseline to Month 3

+30 more

Other study objectives

Semi-structured interview

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosingExperimental Treatment1 Intervention

All participants undergoing thrice-weekly hemodialysis (HD) on the Monday-Wednesday-Friday (MWF) schedule will be assigned to the empagliflozin 25 mg thrice-weekly post-hemodialysis dosing arm (Group I).

Group II: Empagliflozin 10 mg daily dosingExperimental Treatment1 Intervention

Patients undergoing thrice-weekly hemodialysis (HD) on the Tuesday-Thursday-Saturday (TTS) schedule, patients on twice-weekly HD, or patients on peritoneal dialysis will receive empagliflozin 10 mg daily (Group II).

0 / 11Eligibility criteria met