Efficacy and Safety of Empagliflozin in NODAT

Kidney Transplant; Complications Clinical Trial

Official title:

Efficacy and Safety of Empagliflozin Compared With Linagliptin in New-onset Diabetes Mellitus After Kidney Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03642184
• Other study ID #: RJ20180601NODAT
• Status: Terminated
• Phase: Phase 4
• Start date: July 14, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Kidney Transplant; Complications
• New Onset Diabetes After Transplant

Intervention

Drug:
• Empagliflozin
Dosage adjustment based on glucose targets . Once daily
• Linagliptin
Dosage adjustment based on glucose targets. Once daily

Locations

Country	Name	City	State
China	Department of nephrology, endocrinology and kidney transplantation , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR	the change from baseline in estimated glomerular filtration rate calculated by MDRD formula	24 weeks
Secondary	Graft loss rate	the frequency of patients' graft loss or dysfunction	24 weeks
Secondary	Mortality rate	the patients' death rate related to treatment and transplantation with in 24 weeks after treatment	24 weeks
Secondary	Acute rejection	the frequency of acute rejection	24 weeks
Secondary	Progression to albuminuria	the frequency of macroalbuminuria	24 weeks
Secondary	Progression to macroalbuminuria	the frequency of macroalbuminuria	24 weeks
Secondary	Fasting plasma glucose	Change from baseline in fasting plasma glucose	24 weeks
Secondary	Glycated hemoglobin (HbA1c)	Change from baseline in HbA1c	24 weeks
Secondary	Adverse events	Record adverse events that related to treatment and transplantation	24 weeks