New Onset Diabetes After TransplantPhase 4NCT03642184
Efficacy and Safety of Empagliflozin in NODAT
A Phase 4 study testing Empagliflozin and Linagliptin in people with New Onset Diabetes After Transplant and Kidney Transplant; Complications, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- New Onset Diabetes After Transplant, Kidney Transplant; Complications
- What is being tested?
- Empagliflozin and Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2018to 31 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of nephrology, endocrinology and kidney transplantation , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Efficacy and Safety of Empagliflozin Compared With Linagliptin in New-onset Diabetes Mellitus After Kidney Transplantation
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.
Read the 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.
- Being tested
- Empagliflozin, Linagliptin
- Keywords
- empagliflozin, linagliptin, diabetes, kidney transplantation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Dosage adjustment based on glucose targets . Once daily
LinagliptinDrug
Also called Tradjenta
Dosage adjustment based on glucose targets. Once daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | Jardiance 10mg/25mg Film-coated tablets， once daily Receives: Drug: Empagliflozin |
| Linagliptin | Active comparator | Trajenta 5mg Film-coated tablets， once daily Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
the change from baseline in estimated glomerular filtration rate calculated by MDRD formula
Measured: 24 weeks
Secondary outcomes (8)
Graft loss rate
the frequency of patients' graft loss or dysfunction
Measured: 24 weeks
Mortality rate
the patients' death rate related to treatment and transplantation with in 24 weeks after treatment
Measured: 24 weeks
Acute rejection
the frequency of acute rejection
Measured: 24 weeks
Progression to albuminuria
the frequency of macroalbuminuria
Measured: 24 weeks
Progression to macroalbuminuria
the frequency of macroalbuminuria
Measured: 24 weeks
Fasting plasma glucose
Change from baseline in fasting plasma glucose
Measured: 24 weeks
Glycated hemoglobin (HbA1c)
Change from baseline in HbA1c
Measured: 24 weeks
Adverse events
Record adverse events that related to treatment and transplantation
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start14 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Difficult in enrolling suitable participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for New Onset Diabetes After TransplantStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Ni, Dr., Study chair, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Shan Mou, Dr., Study director, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Yaomin Hu, Dr., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Ming Zhang, Dr., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642184
- Sponsor's protocol ID
- RJ20180601NODAT
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32803882
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Empagliflozin Compared With Linagliptin in New-onset Diabetes Mellitus After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03642184
- Acronym / sponsor ID
- RJ20180601NODAT
- Keywords
- empagliflozin, linagliptin, diabetes, kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult in enrolling suitable participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 14 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Drug: EmpagliflozinJardiance 10mg/25mg Film-coated tablets， once daily |
| Linagliptin | Active comparator | Drug: LinagliptinTrajenta 5mg Film-coated tablets， once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: JardianceDosage adjustment based on glucose targets . Once daily | Drug | Empagliflozin |
| LinagliptinAlso: TradjentaDosage adjustment based on glucose targets. Once daily | Drug | Linagliptin |
Primary outcome
eGFR
Time frame: 24 weeks
the change from baseline in estimated glomerular filtration rate calculated by MDRD formula
8 secondary outcomes
Graft loss rate
Time frame: 24 weeks
Mortality rate
Time frame: 24 weeks
Acute rejection
Time frame: 24 weeks
Progression to albuminuria
Time frame: 24 weeks
Progression to macroalbuminuria
Time frame: 24 weeks
Fasting plasma glucose
Time frame: 24 weeks
Glycated hemoglobin (HbA1c)
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Difficult in enrolling suitable participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 32803882Lo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Ni, Dr. study chair
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Shan Mou, Dr. study director
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Yaomin Hu, Dr. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin and Linagliptin in people with New Onset Diabetes After Transplant and Kidney Transplant; Complications, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficult in enrolling suitable participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03642184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.