Safety and Efficacy of Empagliflozin in Hemodialysis

NCT05786443 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 22-01497
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (4)

• Change in Extracellular Volume from Baseline to 12 Weeks

  Extracellular volume is the sum of the plasma volume and interstitial fluid volume.

  Baseline, Week 12

• Change in Intracellular Volume from Baseline to 12 Weeks

  Intracellular volume is the fluid content within the body's cells.

  Baseline, Week 12

• Change in Total Body Water from Baseline to 12 Weeks

  Baseline, Week 12

• Change in 24-Hour Urine Volume from Baseline to 12 Weeks

  Urine volume over a 24-hour period.

  Baseline, Week 12

Secondary Outcomes (11)

• Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks

  Baseline, Week 12

• Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks

  Baseline, Week 12

• Change in Heart Rate Variability from Baseline to 12 Weeks

  Baseline, Week 12

• Incidence of Intra-Dialytic Hypotension

  Up to Week 12

• Incidence of Inter-Dialytic Hypotension

  Up to Week 12

Other Outcomes (3)

• Recruitment Rate

  Up to Week 12

• Withdrawal Rate

  Up to Week 12

• Percentage of Participants Lost to Follow-Up

  Up to Week 12

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.

Also known as: Jardiance

Empagliflozin

Placebo DRUG

Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years on maintenance hemodialysis (HD) with residual kidney function
• Thrice-weekly HD
• Willingness and capacity to provide informed consent
• For women of childbearing potential, a negative pregnancy test is required at screening

You may not qualify if:

• Does not have capacity to consent
• Anuria (daily urine volume \< 200 mL/day)
• Planned kidney transplant within 3 months
• Recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis)
• New York Heart Association (NYHA) Class IV heart failure (HF)
• Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks
• History of diabetic ketoacidosis
• Type 1 Diabetes Mellitus
• Hereditary glucose-galactose malabsorption or primary renal glucosuria
• Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease
• Active malignancy (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ) defined as malignancy under active treatment with chemotherapy, radiation or immunotherapy, or being treated as palliative.
• Major surgery within 12 weeks
• Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening
• Combination use of angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB)
• Current use of an SGLT2 inhibitor (within 6 weeks prior to randomization)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• NYU Langone Health: lead
• Boehringer Ingelheim: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 021215, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Officials

• David Charytan, MS, MSc

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Charytan, MD, MSc

CONTACT

617-935-1572; David.Charytan@nyulangone.org

Zoe Rimler

CONTACT

212-263-2544; Zoe.Rimler@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: January 31, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)