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Efficacy and Safety of Empagliflozin in NODAT

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ClinicalTrials.gov Identifier: NCT03642184
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
New Onset Diabetes After Transplant Kidney Transplant; Complications Drug: Empagliflozin Drug: Linagliptin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Empagliflozin Compared With Linagliptin in New-onset Diabetes Mellitus After Kidney Transplantation
Actual Study Start Date : July 14, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Empagliflozin
Jardiance 10mg/25mg Film-coated tablets, once daily
Drug: Empagliflozin
Dosage adjustment based on glucose targets . Once daily
Other Name: Jardiance

Active Comparator: Linagliptin
Trajenta 5mg Film-coated tablets, once daily
Drug: Linagliptin
Dosage adjustment based on glucose targets. Once daily
Other Name: Tradjenta




Primary Outcome Measures :
  1. eGFR [ Time Frame: 24 weeks ]
    the change from baseline in estimated glomerular filtration rate calculated by MDRD formula


Secondary Outcome Measures :
  1. Graft loss rate [ Time Frame: 24 weeks ]
    the frequency of patients' graft loss or dysfunction

  2. Mortality rate [ Time Frame: 24 weeks ]
    the patients' death rate related to treatment and transplantation with in 24 weeks after treatment

  3. Acute rejection [ Time Frame: 24 weeks ]
    the frequency of acute rejection

  4. Progression to albuminuria [ Time Frame: 24 weeks ]
    the frequency of macroalbuminuria

  5. Progression to macroalbuminuria [ Time Frame: 24 weeks ]
    the frequency of macroalbuminuria

  6. Fasting plasma glucose [ Time Frame: 24 weeks ]
    Change from baseline in fasting plasma glucose

  7. Glycated hemoglobin (HbA1c) [ Time Frame: 24 weeks ]
    Change from baseline in HbA1c

  8. Adverse events [ Time Frame: 24 weeks ]
    Record adverse events that related to treatment and transplantation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642184


Contacts
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Contact: Shan Mou, Dr. +8613918221242 shan_mou@126.com
Contact: Yaomin Hu, Dr. +86‭13651617002‬ amin99@163.com

Locations
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China, Shanghai
Department of nephrology, endocrinology and kidney transplantation , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Shan Mou, Dr.    +8613918221242    shan_mou@126.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Zhaohui Ni, Dr. Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study Director: Shan Mou, Dr. Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Principal Investigator: 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

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03642184     History of Changes
Other Study ID Numbers: RJ20180601NODAT
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by RenJi Hospital:
empagliflozin
linagliptin
diabetes
kidney transplantation

Additional relevant MeSH terms:
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Empagliflozin
Linagliptin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors