Other Clinical Trial - Efficacy & Safety of Empagliflozin in NODAT

Status Terminated

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus
Kidney Transplant; Complications
New Onset Diabetes After Transplant

Clinical Trial Details

NCT number	NCT03642184
Study type	Interventional
Source	RenJi Hospital
Contact
Status	Terminated
Phase	Phase 4
Start date	July 14, 2018
Completion date	January 31, 2019

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of Empagliflozin in NODAT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms