UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036183 |
|---|---|
| Receipt number | R000041225 |
| Scientific Title | Mechanism and efficacy of SGLT2 inhibitor in diabetes patients with renal anemia |
| Date of disclosure of the study information | 2019/03/15 |
| Last modified on | 2019/03/14 08:48:16 |
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Basic information
Public title
Efficacy of SGLT2 inhibitor
Acronym
Efficacy of SGLT2 inhibitor
Scientific Title
Mechanism and efficacy of SGLT2 inhibitor in diabetes patients with renal anemia
Scientific Title:Acronym
SGLT2 inhibitor and renal anemia
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the mechanism of hemopoiesis by SGLT2 inhibitor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemoglobin concentration, erythropoietin concentration
Key secondary outcomes
albuminuria, eGFR, urinary biomarkers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Canagliflozin 100mg daily, 12 weeks
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
1. Type 2 diabetes (HbA1c<10.0%)
2. eGFR > 45 mL/min/1.73m2
3. Albuminuria > 30mg/gCr
4. Hb < 13.5g/dL
5. Age > 19 years old
Key exclusion criteria
1. Intotelance for SGLT2 inhibitors
2. Past history of SGLT2 inhibitor before to 4 weeks at enrollment
3. Past history of administration of ESA before 12 weeks at enrollment
4. Ftn <50 ng/mL and TSAT <20%
5. HbA1c > 10.0%
6. Type 1 diabetes
7. eGFR<45mL/min/1.73m2
8. Pregnancy
9. alchol misuse
10. Severe ketosis, infection, and coma
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University Itabashi Hospital
Division name
Nephrology, Hypertension and Endocrinology
Zip code
173-8610
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University Itabashi Hospital
Division name
Nephrology, Hypertension and Endocrinology
Zip code
173-8610
Address
30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
abe.masanori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Tanabe Mitsubishi Pharm Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
abe.masanori@nihon-u.ac.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
| 2019 | Year | 03 | 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
9
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
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041225
