Efficacy and Safety of Empagliflozin in NODAT

NCT ID: NCT03642184

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-14
• Study Completion Date: 2019-01-31

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.

Detailed Description

In recent years, with the development of transplantation technology and immunosuppressive agents, kidney transplantation has made considerable progress. However, for metabolic disorders after kidney transplantation, such as new diabetes after kidney transplantation, there is still insufficient awareness. Since 1964, Starlz et al. first discovered and proposed New-onset diabetes after kidney transplantation（NODAT） in patients after renal transplantation. Scholars from all countries have paid considerable attention to it. The Chinese guidelines indicate that NODAT can increase the risk of graft-related complications, such as rejection, graft loss and infection, and ultimately affect the long-term survival of the recipient. In addition, NODAT has also been shown to increase the risk of cardiovascular events, and cardiovascular disease is associated with more than half of kidney transplant deaths. A retrospective study of 567 renal transplant recipients in China showed that the incidence of NODAT was 24.2%. It can be seen that the incidence of new-onset diabetes after renal transplantation is high and has long-term adverse effects on transplant patients. Therefore, there is an urgent need to evaluate and investigate NODAT's therapeutic drug regimens.

According to the study, empagliflozin has a protective effect on the kidney and cardiovascular system, but it has not yet been written into the treatment guidelines for new-onset diabetes after kidney transplantation. Metformin and linagliptin are frequently used in diabetics after renal transplantation, and linagliptin also have a protective effect on the kidneys. Therefore, this experiment wanted to compare the effects between empagliflozin and linagliptin on kidney protection.

Conditions

New Onset Diabetes After Transplant; Kidney Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empagliflozin

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

Group Type: ACTIVE_COMPARATOR

Empagliflozin

Intervention Type: DRUG

Dosage adjustment based on glucose targets . Once daily

Linagliptin

Trajenta 5mg Film-coated tablets， once daily

Group Type: ACTIVE_COMPARATOR

Linagliptin

Intervention Type: DRUG

Dosage adjustment based on glucose targets. Once daily

Interventions

Empagliflozin

Dosage adjustment based on glucose targets . Once daily

Intervention Type: DRUG

Linagliptin

Dosage adjustment based on glucose targets. Once daily

Intervention Type: DRUG

Other Intervention Names

Jardiance; Tradjenta

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Ni, Dr.

Role: STUDY_CHAIR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shan Mou, Dr.

Role: STUDY_DIRECTOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Yaomin Hu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Ming Zhang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32803882 (View on PubMed)

Other Identifiers

RJ20180601NODAT

Identifier Type: -

Identifier Source: org_study_id