NCT03642184

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

July 16, 2018

Last Update Submit

November 22, 2023

Conditions

New Onset Diabetes After TransplantKidney Transplant; Complications

Keywords

empagliflozinlinagliptindiabeteskidney transplantation

Outcome Measures

Primary Outcomes (1)

  • eGFR

    the change from baseline in estimated glomerular filtration rate calculated by MDRD formula

    24 weeks

Secondary Outcomes (8)

  • Graft loss rate

    24 weeks

  • Mortality rate

    24 weeks

  • Acute rejection

    24 weeks

  • Progression to albuminuria

    24 weeks

  • Progression to macroalbuminuria

    24 weeks

  • +3 more secondary outcomes

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

Jardiance 10mg/25mg Film-coated tablets， once daily

Drug: Empagliflozin

Linagliptin

ACTIVE COMPARATOR

Trajenta 5mg Film-coated tablets， once daily

Drug: Linagliptin

Interventions

EmpagliflozinDRUG

Dosage adjustment based on glucose targets . Once daily

Also known as: Jardiance
Empagliflozin
LinagliptinDRUG

Dosage adjustment based on glucose targets. Once daily

Also known as: Tradjenta
Linagliptin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single kidney transplantation
  • Normal glucose tolerance or Pre-Diabetes mellitus before transplantation
  • According to Oral glucose tolerance test results to make the diagnosis of NODAT
  • Standard triple immunosuppression therapy
  • HbA1c≤10%
  • Steady hormone usage
  • BMI 18.5-30kg/m2
  • Patient informed consent

You may not qualify if:

  • Diabetes patients before transplantation
  • Pregnancy pregnancy
  • Type 1 diabetes after kidney transplantation
  • Severe liver function impairment (AST/ALT 3 times standard value)
  • Severely impaired renal function (eGFR\<45)
  • Having uncontrolled diseases
  • History of cancer in the past 5 years (except basal cell carcinoma) and/or cancer treatment
  • Participating in another trial involving the study drug with in 30 days
  • Premenopausal women (1 year before the last menstrual period ≤ informed consent)
  • Alcohol or drug abuse within 3 months of informed consent, affecting compliance Need other drugs to control NODAT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of nephrology, endocrinology and kidney transplantation , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

    PMID: 32803882DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozinLinagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Zhaohui Ni, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    STUDY CHAIR

  • Shan Mou, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    STUDY DIRECTOR

  • Yaomin Hu, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

  • Ming Zhang, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 22, 2018

Study Start

July 14, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

CN(1)