Empagliflozin in ESKD - A Feasibility Study

Conditions

• Heart Failure
• Kidney Failure, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing — DRUG
  Participants in Group I will be asked to take empagliflozin 25 mg after each hemodialysis session at home.
• Empagliflozin 10 mg daily dosing — DRUG
  Participants assigned to Group II will be asked to take empagliflozin 10 mg each morning between 8:30 and 9:30 a.m. at home.

Study Details

The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.

Key Dates

Start date

Nov 1, 2023

Status verified

May 2026

Primary completion

May 4, 2026

Completion

Jun 20, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing
  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).
• Experimental: Empagliflozin 10 mg daily dosing
  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).

Primary Outcome Measure

Proportion of eligible patients out of screened patients [ Time Frame: During the screening process ]

Locations (2)

Find similar trials in Jackson, MS

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