End Stage Renal DiseasePhase 2SEEDNCT05786443
Safety and Efficacy of Empagliflozin in Hemodialysis
A Phase 2 study testing Empagliflozin 10 MG in people with End Stage Renal Disease, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 021215
NYU Langone Health
New York, New York, 10016
About this study
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
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
- Being tested
- Empagliflozin 10 MG, Placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Jardiance
Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.
PlaceboDrug
Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks. Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Extracellular Volume from Baseline to 12 Weeks
Extracellular volume is the sum of the plasma volume and interstitial fluid volume.
Measured: Baseline, Week 12
Change in Intracellular Volume from Baseline to 12 Weeks
Intracellular volume is the fluid content within the body's cells.
Measured: Baseline, Week 12
Change in Total Body Water from Baseline to 12 Weeks
Measured: Baseline, Week 12
Change in 24-Hour Urine Volume from Baseline to 12 Weeks
Urine volume over a 24-hour period.
Measured: Baseline, Week 12
Secondary outcomes (11)
Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks
Albumin excreted in the urine over a 24-hour period.
Measured: Baseline, Week 12
Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks
Blood pressure measured over a 24-hour period.
Measured: Baseline, Week 12
Change in Heart Rate Variability from Baseline to 12 Weeks
Variance in time between the heart beats.
Measured: Baseline, Week 12
Incidence of Intra-Dialytic Hypotension
Intra-dialytic hypotension defined as nadir systolic blood pressure (SBP) <90 mmHg if pre-HD SBP≤160 mmHg, or nadir SBP <100 mmHg if pre-HD SBP >160 mmHg.
Measured: Up to Week 12
Incidence of Inter-Dialytic Hypotension
Inter-dialytic hypotension defined symptomatic SBP <90 mmHg or hypotension requiring adjustment in blood pressure medications or treatment in an emergency or hospitalized setting.
Measured: Up to Week 12
Incidence of Serious Hypotension
Defined as hypotension requiring hospitalization, emergency room (ER) visit, or reduction of blinded study medication or other anti-hypertensive medications.
Measured: Up to Week 12
Incidence of Non-Serious Hypoglycemia
Detected via clinical lab data.
Measured: Up to Week 12
Incidence of Serious Hypoglycemia
Defined as hypoglycemia requiring hospitalization, emergency room (ER) visit or the combination of glucose<70 mg/dL and urgent glucagon or carbohydrate use.
Measured: Up to Week 12
Incidence of Ketoacidosis
Defined as metabolic state associated with pathologically high serum and urine concentrations of ketone bodies.
Measured: Up to Week 12
Number of Adverse Events
Measured: Up to Week 12
Number of Serious Adverse Events
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start31 Jan 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- David Charytan, MS, MSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786443
- Sponsor's protocol ID
- 22-01497
- Acronym
- SEED
- Status last verified
- Nov 2026
- First submitted
- 15 Mar 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05786443
- Acronym / sponsor ID
- SEED / 22-01497
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boehringer Ingelheim
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 10 MGParticipants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: JardianceSodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet. | Drug | Empagliflozin |
| PlaceboEmpagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet. | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Charytan, MS, MSc principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10 MG in people with End Stage Renal Disease, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Extracellular Volume from Baseline to 12 Weeks (time frame: Baseline, Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.