UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043519 |
|---|---|
| Receipt number | R000049693 |
| Scientific Title | Effects of the SGLT2 inhibitor on erythropoiesis and iron homeostasis in patients with type 2 diabetes and chronic kidney disease |
| Date of disclosure of the study information | 2021/03/04 |
| Last modified on | 2023/01/16 11:58:56 |
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Basic information
Public title
Effects of the SGLT2 inhibitor on erythropoiesis and iron homeostasis in patients with type 2 diabetes and chronic kidney disease
Acronym
Effects of the SGLT2 inhibitor on erythropoiesis and iron homeostasis in patients with type 2 diabetes and chronic kidney disease
Scientific Title
Effects of the SGLT2 inhibitor on erythropoiesis and iron homeostasis in patients with type 2 diabetes and chronic kidney disease
Scientific Title:Acronym
Effects of the SGLT2 inhibitor on erythropoiesis and iron homeostasis in patients with type 2 diabetes and chronic kidney disease
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of dapagliflozin administration for 12 weeks on erythropoiesis and iron homeostasis as compared with baseline levels in patients with type 2 diabetes and chronic kidney disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of parameters of the erythropoiesis (RBCs, Hb, Hct, CHr, EPO, MCV) and iron homeostasis (ferritin, TSAT, hepcidin) at 12 weeks after dapagliflozin administration
Key secondary outcomes
Changes of several parameters at 12 weeks after dapagliflozin administration
1.BIA and body composition analysis
2.HbA1c and BMI
3.Uric acid, Cre, eGFR, UACR, and urine sodium
4.AST, ALT, and gamma-GTP
5.Total, HDL, and LDL cholesterol, and TG
6.Severe adverse events
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants in the study must have insufficient glycemic control under diet and exercise and/or treatment with hypoglycemic drugs other than SGLT2 inhibitors. Patients will be considered eligible for the study if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below.
1.Patients providing written informed consent to participate in the study
2.Aged >=60 years (irrespective of sex)
3.HbA1c level >6.5, <10.0 mg/dL within 8 weeks before consent (patient receiving insulin, sulfonylureas or glinides: >=7.0%)
4.eGFR level >30, <60 mL/min/1.73m2 before consent
5.anemia of chronic kidney disease defined as hemoglobin < 12.0 g/dL without iron deficiency defined as serum ferritin levels > 50 ng/mL before consent
6.patients who have not change dosage and administration of drugs for hypoglycemic drugs, ESA, and iron from at least 8 weeks before the date of consent
Key exclusion criteria
1.Type 1 diabetes
2.Patients with severe ketosis, diabetic coma or pre-coma, severe infection, perioperative, or severe trauma
3.Patients with severe renal dysfunction or treated with hemodialysis for end-stage renal disease
4.History of acute coronary syndrome, cerebrovascular disease, myocarditis, contractile pericarditis, or severe valvular disease within 12 weeks before consent
5.NYHA cardiac function classification of IV
6.BMI <18.5 kg/m2
7.Pregnant, breast-feeding, or possibly pregnant women
8.Diagnosed or suspected malignant tumors (patients who do not have a treatment history of anticancer therapy within 1 year before consent, and have no plan to do so will not be excluded)
9.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Osonoi |
Organization
Naka Kinen Clinic
Division name
Director
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Ofuchi |
Organization
Naka Kinen Clinic
Division name
Clinical Labratory
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Naka Kinen Clinic
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Nakakinen clinic
Address
745-5 Nakadai, Naka-shi, Ibaraki
Tel
029-353-2800
t-osonoi@kensei-kai.com
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
那珂記念クリニック（茨城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.jinzouzaidan.or.jp/jigyou/pdf/2021_summary_rpg/JKFB20-9.pdf
Number of participants that the trial has enrolled
14
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
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Dapagliflozin-induced SGLT2 inhibition for 12 weeks is associated with small increases in hematocrit, hemoglobin, serum erythropoietin concentrations, and reticulocytes.
Management information
Registered date
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049693
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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