NCT05786443 · NYU Langone Health
Safety and Efficacy of Empagliflozin in Hemodialysis
(SEED)
What this study is about
A 12-week, phase II, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, multi-center study to assess the safety, tolerability, and preliminary effectiveness of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.
View original scientific description
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
Extracellular volume is the sum of the plasma volume and interstitial fluid volume.
Change in Intracellular Volume from Baseline to 12 Weeks
Time frame: Baseline, Week 12
Intracellular volume is the fluid content within the body's cells.
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
Urine volume over a 24-hour period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 norma
Where
- Boston, Massachusetts
- New York, New York
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boehringer Ingelheim
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations