UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050853 |
|---|---|
| Receipt number | R000057945 |
| Scientific Title | Oral semaglutide in kidney transplant recipients with metabolic syndrom |
| Date of disclosure of the study information | 2023/04/15 |
| Last modified on | 2023/04/14 17:39:26 |
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Basic information
Public title
Oral semaglutide in kidney transplant recipients with metabolic syndrome: three Japanese cases.
Acronym
Oral semaglutide in kidney transplant recipients
Scientific Title
Oral semaglutide in kidney transplant recipients with metabolic syndrom
Scientific Title:Acronym
Oral semaglutide in kidney transplant recipients
Region
| Japan |
Condition
Condition
Kidney transplant recipients with metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Weight loss effect of oral semaglutide.
Basic objectives2
Others
Basic objectives -Others
Effect of oral semaglutide on eGFR
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in body weight after 12 months of oral semaglutide administration
Key secondary outcomes
Change in eGFR 12 months after initiation of oral semaglutide
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Post renal transplant recipient with metabolic syndrome complications
Key exclusion criteria
Insulin user
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | RYOICHI |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
+81-776-21-1277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | RYOICHI |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
+81-776-21-1277
Homepage URL
http://www.fujita-mhp.jp/
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital
Institute
Department
Personal name
RYOICHI MIYAZAKI
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Fujita Memorial Hospital
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui General Hospital
Address
58-16-1, Egami-cho, Fukui City
Tel
+81-776-59-1300
masa1960@ruby.ocn.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
3
Results
Three renal transplant recipients with metabolic syndrome received oral semaglutide for 12 months. All patients lost weight and had no change in eGFR.
Results date posted
| 2023 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
To be submitted to RTT now.
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 30 | Day |
Baseline Characteristics
Renal transplant recipient with metabolic syndrome
Participant flow
Patients were included in the study from December 2021 through January 2022. Oral semaglutide was started at 3 mg/day, according to the package insert, and the dose was titrated up to a final dose of 14 mg/day.
Adverse events
One patient had severe nausea and the dose escalation was very gradual. No adverse events were observed in the other two patients.
Outcome measures
Weight loss effect of oral semaglutide administration
Plan to share IPD
For patients with severe nausea, the oral semaglutide dose was temporarily lowered to 1.5 mg/day, and thereafter the dose was increased at approximately 4-week intervals, culminating in a 14 mg/day dose.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Three renal transplant recipients with metabolic syndrome complications were treated with oral semaglutide for 12 months. Weight loss ranged from 2.7 to 12.2 kg. eGFR did not change, and no patients dropped out due to adverse events.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057945
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