Empagliflozin in ESKD - A Feasibility Study

NCT05687058 | Recruiting Phase 1 FDA Drug

• 1 other identifier: UMMC-Neph-EMPESKD-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Kidney Failure, Chronic; Heart Failure

Keywords

empagliflozin; end-stage kidney disease; pharmacokinetics; pharmacodynamics; feasibility trial; heart failure; residual kidney function; Sodium-glucose transporter type 2 inhibitor

Outcome Measures

Primary Outcomes (21)

• Proportion of eligible patients out of screened patients

  During the screening process

• Success rate of obtaining consent from those eligible patients

  During the enrollment process

• Proportion of missing doses

  The investigators will do pill count using medication bottles and calculate the proportion of missing doses from each patient.

  3 months

• Proportion of empagliflozin discontinuation

  Proportion of participants who discontinue empagliflozin for any reason

  3 months

• Dropout rate

  Proportion of participants who dropped out from the study for any reason

  3 months

• Length of time on continuous glucose monitoring

  Continuous glucose monitoring will be done for up to 14 days.

  3 months

• Completion rate of timed urine collection

  3 months

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

  The 1st blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  Immediately before the first dose

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

  The 2nd blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 30 minutes of the first dose

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

  The 3rd blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 1 hour of the first dose

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

  The 4th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 1.5 hours of the first dose

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

  The 5th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 2 hours of the first dose

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

  The 6th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 3 hours of the first dose

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

  The 7th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 4 hours of the first dose

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

  The 8th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 8 hours of the first dose

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

  The 9th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 12 hours of the first dose

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

  The 10th blood draw for the pharmacokinetic study among patients on peritoneal dialysis

  At 24 hours of the first dose

• Random blood empagliflozin level

  Time since the last dose will be recorded.

  At Month 1

• Random blood empagliflozin level

  Time since the last dose will be recorded.

  At Month 2

• Random blood empagliflozin level

  Time since the last dose will be recorded.

  At Month 3

• Peritoneal dialysis clearance of empagliflozin

  Peritoneal dialysis fluid will be collected for 24 hours.

  At Month 3

Secondary Outcomes (66)

• Number of Participants with Hepatic injury

  3 months

• Number of Participants with Ketoacidosis

  3 months

• Number of Participants with Lower limb amputation

  3 months

• Number of Participants with Symptomatic urinary tract infection

  3 months

• Number of Participants with genital infection

  3 months

Other Outcomes (1)

• Semi-structured interview

  3 months

Study Arms (2)

Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing

EXPERIMENTAL

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).

Drug: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing

Empagliflozin 10 mg daily dosing

EXPERIMENTAL

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).

Drug: Empagliflozin 10 mg daily dosing

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.

Also known as: Jardiance 25 mg thrice-weekly post-hemodialysis dosing

Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing

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.

Also known as: Jardiance 10 mg daily dosing

Empagliflozin 10 mg daily dosing

Eligibility Criteria

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

You may qualify if:

• age ≥18 years;
• diagnosis of end-stage kidney disease requiring dialysis, and
• ability to provide informed consent.

You may not qualify if:

• systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
• two or more episodes of urinary tract infection within the last 12 months
• history of urinary retention or urinary tract obstruction
• liver cirrhosis
• advanced heart failure requiring heart assist device or inotropic support
• heart or liver transplant recipient
• major surgery performed within the last 3 months ("major" per the investigator's assessment)
• major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)
• active cancer
• pregnant or lactating women
• known allergy or hypersensitivity to any SGLT2 inhibitors
• history of ketoacidosis during the last 12 months
• any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (2)

University of Mississippi Medical Center

Jackson, Mississippi, 39157, United States

RECRUITING

Jackson Medicall Mall Dialysis Clinic

Jackson, Mississippi, 39213, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; 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; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yoshitsugu Obi, MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshitsugu Obi, MD, PhD

CONTACT

601-984-5670; yobi@umc.edu

Rachael Thompson

CONTACT

(601)496-7822; rthompson3@umc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, non-randomized, two-arm intervention study

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: January 17, 2023
• Study Start: November 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available upon request after one month until 60 months of the publication of the manuscript.

Locations

US (2)