UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039129 |
|---|---|
| Receipt number | R000044625 |
| Scientific Title | Study on renal function decline in type 2 diabetes with CKD stage 3 |
| Date of disclosure of the study information | 2020/01/11 |
| Last modified on | 2020/01/11 14:13:02 |
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Basic information
Public title
Study on renal function decline in type 2 diabetes with CKD stage 3
Acronym
Study on renal function decline in type 2 diabetes with CKD stage 3
Scientific Title
Study on renal function decline in type 2 diabetes with CKD stage 3
Scientific Title:Acronym
Study on renal function decline in type 2 diabetes with CKD stage 3
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether appropriate treatment under daily outpatient care supress renal function decline in type 2 diabetes with CKD stage 3.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR changes
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with CKD stage 3 visiting our department during January to March in 2017
Key exclusion criteria
Patients who are judged to be inappropriate as subject by the investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sou |
| Middle name | |
| Last name | Nagai |
Organization
NTT-East Sapporo Hospital
Division name
Department of diabetes and endocrinology
Zip code
0600061
Address
Nishi 15, Minami 1, Chuuou-ku, Sapporo, Hokkaido, JAPAN
TEL
011-623-7000
smc.webmaster-ml@east.ntt.co.jp
Public contact
Name of contact person
| 1st name | Sou |
| Middle name | |
| Last name | Nagai |
Organization
NTT-East Sapporo Hospital
Division name
Department of diabetes and endocrinology
Zip code
0600061
Address
Nishi 15, Minami 1, Chuuou-ku, Sapporo, Hokkaido, JAPAN
TEL
011-623-7000
Homepage URL
smc.webmaster-ml@east.ntt.co.jp
Sponsor or person
Institute
NTT-East Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
NTT-East Sapporo Hospital
Address
Nishi 15, Minami 1, Chuuou-ku, Sapporo, Hokkaido, JAPAN
Tel
011-623-7000
smc.webmaster-ml@east.ntt.co.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 | 01 | Month | 11 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ovserve eGFR to 2021
Management information
Registered date
| 2020 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044625
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
