Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05614115
Phase
PHASE1
Status
Completed

Conditions

  • Diabetic
  • Dialysis
  • End-stage Kidney Disease
  • Hemodialysis
  • Kidney Disease, Chronic
  • Kidney Dysfunction
  • Kidney Failure
  • Non-diabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.
  • Placebo — OTHER
    Placebo comparator

Study Details

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

Key Dates

Start date
Mar 21, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin 10mg
    Empagliflozin10mg oral: Those randomized to 10 mg daily dose will be treated with 10 mg QD throughout the dose escalation and the treatment phase for a total of 12 weeks.
  • Experimental: Empagliflozin 25mg
    Empagliflozin 25 mg oral: Those randomized to 25 mg daily dose will be treated with 10 mg QD for the first 2 weeks before escalating the dose to 25 mg QD in week 3, based on tolerability. At the end of the dose-escalation phase (weeks 3-4), participants will continue the randomized assignment for additional 8 weeks (weeks 5-12, treatment phase), for a total of 12 weeks.
  • Placebo Comparator: Placebo
    Encapsulated placebo with an identical appearance to empagliflozin: Those randomized to placebo will be treated with an oral placebo QD throughout the dose escalation and the treatment phase for a total of 12 weeks.

Primary Outcome Measure

The proportion of participants in each intervention group who remain in follow-up and adhere to the full randomized dose of empagliflozin at the end of the 12-week intervention period. [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84132-

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University of Utah· Salt Lake City, UT

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