UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061247 |
|---|---|
| Receipt number | R000070088 |
| Scientific Title | The effect of canagliflozin on renal function in elderly patients with type 2 diabetes who retained cardiac function (Sub-analysis of the Canonical Study) |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/13 23:01:05 |
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Basic information
Public title
The effect of canagliflozin on renal function in elderly patients with type 2 diabetes who retained cardiac function (Sub-analysis of the Canonical Study)
Acronym
Canonical Sub-analysis
Scientific Title
The effect of canagliflozin on renal function in elderly patients with type 2 diabetes who retained cardiac function (Sub-analysis of the Canonical Study)
Scientific Title:Acronym
Canonical Sub-analysis
Region
| Japan |
Condition
Condition
Elderly (65 years or older) patients with type 2 diabetes and HFpEF
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using existing data from the Canonical Study, we will confirm whether the effects of canaglifrongin on anemia biomarkers and renal function markers in "elderly (65 years or older) type 2 diabetic patients with HFpEF" are consistent with those reported in large-scale clinical trials using other SGLT2i. We will also confirm whether changes in tubular biomarkers (urinary L-FABP and urinary NGAL) in the early stages of SGLT2i administration can be useful indicators for predicting the changes in renal function (eGFR) and renal anemia (Hb, Ht, etc.).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anemia markers (Hb) related to renal anemia
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Total study participants of the CANONICAL study (82 people)
42 patients in Canaglu group, 40 patients in standard treatment group
Key exclusion criteria
A person with missing data for all anemia markers related to renal anemia (Hb, Ht, RBC-count, MCV, MCH) and renal function markers (eGFR).
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | Shimazu |
| Middle name | |
| Last name | Koki |
Organization
Nara Medical University Hospital
Division name
Clinical Research Center
Zip code
634-8522
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
shimkoki-aran@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Shimazu |
| Middle name | |
| Last name | Koki |
Organization
Nara Medical University Hospital
Division name
Clinical Research Center
Zip code
634-8522
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
shimkoki-aran@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744-22-3051
ino_rinri@naramed-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
| 2026 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070088
