RECRUITING

Safety and Efficacy of Empagliflozin in Hemodialysis

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-01-31

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05786443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

David Charytan, MD, MSc

CONTACT

617-935-1572

David.Charytan@nyulangone.org

Zoe Rimler

CONTACT

212-263-2544

Zoe.Rimler@nyulangone.org

Principal Investigator

David Charytan, MS, MSc

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 021215

United States

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

David Charytan, MS, MSc, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-01-31

Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

End Stage Renal Disease