CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04906213
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin10Mg Tab — DRUG
    Empagliflozin10 Mg daily or placebo daily for 18 months
  • Placebo — DRUG
    10Mg Placebo Tab

Study Details

CREST-KT is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). After evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.

Key Dates

Start date
Jul 25, 2022
Status verified
Jan 2026
Primary completion
Jan 22, 2026
Completion
Jan 22, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm I: With Type II Diabetes
    Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
  • Active Comparator: Arm 2: Without Diabetes
    Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo

Primary Outcome Measure

Change in kidney function as measured by eGFR [ Time Frame: Baseline, 6 months, 9 months, 12 months and 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

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