Efficacy and Safety of Empagliflozin in NODAT

Sponsor
RenJi Hospital
Study ID
NCT03642184
Phase
PHASE4
Status
Terminated

Conditions

  • Kidney Transplant; Complications
  • New Onset Diabetes After Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Dosage adjustment based on glucose targets . Once daily
  • Linagliptin — DRUG
    Dosage adjustment based on glucose targets. Once daily

Study Details

This is an open label, randomized controlled study. We'd like to access the safety and effects of empagliflozin compared with linagliptin in new-onset diabetes after kidney transplantation patients. Our primary endpoints are kidney related indicators and secondary endpoints are glucose and lipid metabolism related indicators and adverse events. We are going to recruit 35 patients for each group and follow six months.

Key Dates

Start date
Jul 14, 2018
Status verified
Nov 2023
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin
    Jardiance 10mg/25mg Film-coated tablets， once daily
  • Active Comparator: Linagliptin
    Trajenta 5mg Film-coated tablets， once daily

Primary Outcome Measure

eGFR [ Time Frame: 24 weeks ]

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