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Recruiting NCT05786443

Safety and Efficacy of Empagliflozin in Hemodialysis

Phase II Interventional End Stage Renal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 10 MG, Placebo.
Who it may be relevant to
Registry conditions: End Stage Renal Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Empagliflozin Among Patients Initiating Hemodialysis for the Treatment of End-Stage Kidney Disease

Overview

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.

Interventions

  • Drug Empagliflozin 10 MG
    Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.
  • Drug Placebo
    Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.

Primary outcome measures

  • Change in Extracellular Volume from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
  • Change in Intracellular Volume from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
  • Change in Total Body Water from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
  • Change in 24-Hour Urine Volume from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
Secondary outcome measures (11)
  • Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
  • Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
  • Change in Heart Rate Variability from Baseline to 12 Weeks [Time frame: Baseline, Week 12]
  • Incidence of Intra-Dialytic Hypotension [Time frame: Up to Week 12]
  • Incidence of Inter-Dialytic Hypotension [Time frame: Up to Week 12]
  • Incidence of Serious Hypotension [Time frame: Up to Week 12]
  • Incidence of Non-Serious Hypoglycemia [Time frame: Up to Week 12]
  • Incidence of Serious Hypoglycemia [Time frame: Up to Week 12]
  • Incidence of Ketoacidosis [Time frame: Up to Week 12]
  • Number of Adverse Events [Time frame: Up to Week 12]
  • Number of Serious Adverse Events [Time frame: Up to Week 12]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
  • Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
  • Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
  • Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy.
  • Any condition that in the opinion of the investigator would make participation not in the best interest of the subject

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Brigham and Women's Hospital — Boston
  • NYU Langone Health — New York

Identifiers

NCT: NCT05786443 · 22-01497

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗