Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

NCT05614115 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: IRB_001558251R01DK131265
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

Conditions

End-stage Kidney Disease; Kidney Disease, Chronic; Dialysis; Diabetic; Non-diabetic; Kidney Dysfunction; Kidney Failure; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• The proportion of participants in each intervention group who remain in follow-up and adhere to the full randomized dose of empagliflozin at the end of the 12-week intervention period.

  12 weeks

Secondary Outcomes (5)

• Proportions of participants in each group who reduce and/or discontinue treatment for safety

  12-weeks

• Proportions of participants in each group who reduce and/or discontinue treatment because of intolerance (i.e., allergy, nausea) or other reasons unrelated to safety (i.e., pill burden, study withdrawal due to transplant)

  12-weeks

• Proportions of participants in each group who have ≥ 80% pill count compliance.

  12-weeks

• Dialytic clearance of empagliflozin

  4 hours post-dose during hemodialysis

• Long-term accumulation of empagliflozin

  10 weeks

Study Arms (3)

Empagliflozin 10mg

EXPERIMENTAL

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.

Drug: Empagliflozin

Empagliflozin 25mg

EXPERIMENTAL

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.

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Empagliflozin DRUG

is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Also known as: Jardiance®, CL-JAR-100113 02.28.2022

Empagliflozin 10mg; Empagliflozin 25mg

Placebo OTHER

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• include diabetic and non-diabetic adults
• dialysis treatment history of ≥3 months

You may not qualify if:

• type 1 diabetes
• ongoing intravenous antibiotic therapy for infectious disease
• active treatment for malignancy
• unhealed lower extremity skin ulceration
• history of Fournier's gangrene
• diabetic ketoacidosis
• severe hypoglycemia (requiring external assistance within the past one year)
• allergy to empagliflozin
• pregnancy

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in the Department of Medicine, Division of Nephrology & Hypertension

Model Details: The study will be conducted in two phases, a dose-escalation phase (week 0-4) and a treatment phase (week 5-12).

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 14, 2022
• Study Start: March 21, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)