UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039525 |
|---|---|
| Receipt number | R000045074 |
| Scientific Title | The efficacy of Dulaglutide in patients with diabetes undergoing hemodialysis. |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2020/02/19 09:54:00 |
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Basic information
Public title
The efficacy of Dulaglutide in patients with diabetes undergoing hemodialysis.
Acronym
The efficacy of Dulaglutide in patients with diabetes undergoing hemodialysis.
Scientific Title
The efficacy of Dulaglutide in patients with diabetes undergoing hemodialysis.
Scientific Title:Acronym
The efficacy of Dulaglutide in patients with diabetes undergoing hemodialysis.
Region
| Japan |
Condition
Condition
Patients with diabetes undergoing hemodialysis.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of Dulaglutide in patients with hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycoalbumin
C-peptide levels
Key secondary outcomes
Number of drugs for diabetes treatment.
Hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dulaglutide
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients
Key exclusion criteria
Patients who are considered inappropriate for participation in this study by the investigator's judgement.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Funakoshi |
Organization
Nagasaki Kidney Hospital
Division name
Depertment of nephrology
Zip code
850-0032
Address
5-1Kouzenmachi,Nakasaki-shi,NAGASAKI
TEL
095-824-1101
satoshi2754@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Funakoshi |
Organization
Nagasaki Kidney Hospital
Division name
Depertment of nephrology
Zip code
850-0032
Address
5-1Kouzenmachi,Nagasaki-shi,NAGASAKI
TEL
095-824-1101
Homepage URL
satoshi2754@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Kidney Hospital
Department of nephrology
Institute
Department
Personal name
Funding Source
Organization
Not Applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Kidney Hospital Ethics Committee
Address
5-1Kouzenmachi,Nagasaki-shi,NAGASAKI
Tel
095-824-1101
m-yamashita@nagajin.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
| 2020 | Year | 02 | Month | 18 | 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
18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045074
