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

NCT ID: NCT05614115

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-06-30

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.

Detailed Description

Patients on dialysis have a very high risk of heart failure and heart-related death compared to people who do not require dialysis. While treatment options for heart failure have improved over the years for those without kidney disease, there has been very limited discoveries to improve survival for dialysis patients.

Empagliflozin, a new diabetic medication that works by making the kidney put out more sugar in the urine, has recently shown to have significant efficacy to protect the kidney and to reduce heart failure hospitalization and cardiovascular death in both diabetic and non-diabetic patients. Studies suggest that this medication may have benefits on the heart, fat cells, blood vessels, and possibly other organ systems. The benefit remains consistent whether you have diabetes or not. Empagliflozin is now approved by the U.S. Food and Drug Administration (FDA) to treat not only diabetes but also chronic kidney disease and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults regardless of the diabetes status.

The clinical studies, however, have excluded those with severe kidney disease and those requiring dialysis. The safety of empagliflozin in the dialysis patients has not been established, and thus it is not available for people with end-stage kidney disease. If empagliflozin is safe in dialysis patients, it may potentially become a very powerful tool to lower the risk of heart-related complications and prolong survival.

Although empagliflozin is approved by the FDA to treat patients with chronic kidney disease, heart failure, and/or diabetes, our study will evaluate empagliflozin as an investigational drug to assess if it is safe in patients receiving chronic dialysis. If we can establish safety, the next step would be to conduct a larger clinical study to evaluate its ability to lower heart failure and death risk in dialysis patients.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Empagliflozin 10mg

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 Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

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

Empagliflozin 25mg

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 Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo comparator

Interventions

Empagliflozin

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

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: OTHER

Other Intervention Names

Jardiance®; CL-JAR-100113 02.28.2022

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Monique Cho

Associate Professor in the Department of Medicine, Division of Nephrology & Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

1R01DK131265

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00155825

Identifier Type: -

Identifier Source: org_study_id