Clinical trial NCT05786443: Safety and Efficacy of Empagliflozin in Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Boehringer Ingelheim
First posted: 2023-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Extracellular Volume from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
measure: Change in Intracellular Volume from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
measure: Change in Total Body Water from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
measure: Change in 24-Hour Urine Volume from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
measure: Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
measure: Change in Heart Rate Variability from Baseline to 12 Weeks
timeFrame: Baseline, Week 12
measure: Incidence of Intra-Dialytic Hypotension
timeFrame: Up to Week 12
measure: Incidence of Inter-Dialytic Hypotension
timeFrame: Up to Week 12
measure: Incidence of Serious Hypotension
timeFrame: Up to Week 12
measure: Incidence of Non-Serious Hypoglycemia
timeFrame: Up to Week 12
measure: Incidence of Serious Hypoglycemia
timeFrame: Up to Week 12
measure: Incidence of Ketoacidosis
timeFrame: Up to Week 12
measure: Number of Adverse Events
timeFrame: Up to Week 12
measure: Number of Serious Adverse Events
timeFrame: Up to Week 12
Other outcomes:
measure: Recruitment Rate
timeFrame: Up to Week 12
measure: Withdrawal Rate
timeFrame: Up to Week 12
measure: Percentage of Participants Lost to Follow-Up
timeFrame: Up to Week 12
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Charytan, MS, MSc
role: PRINCIPAL_INVESTIGATOR
References: