UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048277 |
|---|---|
| Receipt number | R000055015 |
| Scientific Title | Renal protective effects of tofogliflozin and changes in clinical parameters affecting renal function in patients with type 2 diabetes |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2024/01/09 13:52:25 |
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Basic information
Public title
Renal protective effects of tofogliflozin and changes in clinical parameters affecting renal function in patients with type 2 diabetes
Acronym
Renoprotective effect of tofogliflozin
Scientific Title
Renal protective effects of tofogliflozin and changes in clinical parameters affecting renal function in patients with type 2 diabetes
Scientific Title:Acronym
Renoprotective effect of tofogliflozin
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Renal protective effects of tofogliflozin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in estimated glomerular filtration rate before and after the initiation of tofogliflozin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who were administered tofogliflozin
Key exclusion criteria
1. Tofogliflozin had already administered at the initial consultation
2. Patients who discontinued treatment or who were transferred to other hospitals during the observation period
3. Patient after renal transplantation
4. Iron preparations were started during the observation period
5. GLP-1 receptor agonists were started during the observation period
6. Antihypertensive agents, diuretics or urate lowering agents were changed during the observation period
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Edogawa Hospital
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
Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
Tel
03-3673-1221
ito@edogawa.or.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
| 2022 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292014
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292014
Number of participants that the trial has enrolled
158
Results
The BW, BP, UP and serum UA decreased from baseline in both eGFR groups while the Hb increased. The eGFR did not significantly differ over time. The change in the eGFR at 12 months after the initiation of tofogliflozin was -1.9 and 0.2 mL/min/1.73 m2 in the normal- and low-eGFR group, respectively. In the normal-eGFR group, the change in the eGFR showed a significant negative correlation with the HbA1c and eGFR at baseline.
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 21 | Day |
Baseline Characteristics
158 patients with type 2 diabetes
Participant flow
158 patients with type 2 diabetes
Adverse events
The frequencies of adverse events specific for SGLT2 inhibitors were not significantly different between the normal- and low-eGFR groups.
Outcome measures
HbA1c, eGFR, body weight, blood pressure, urinary protein excretion, Hb, serum uric acid
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055015
