UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023902 |
|---|---|
| Receipt number | R000027514 |
| Scientific Title | An exploratory clinical study of the renoprotective effect of empagliflozin and the verification of companion diagnostics in type 2 diabetes patients |
| Date of disclosure of the study information | 2016/09/05 |
| Last modified on | 2023/06/20 14:31:57 |
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Basic information
Public title
An exploratory clinical study of the renoprotective effect of empagliflozin and the verification of companion diagnostics in type 2 diabetes patients
Acronym
Renoprotection and companion diagnostics verification in type 2 diabetes patients treated with empagliflozin (RECOVERY)
Scientific Title
An exploratory clinical study of the renoprotective effect of empagliflozin and the verification of companion diagnostics in type 2 diabetes patients
Scientific Title:Acronym
Renoprotection and companion diagnostics verification in type 2 diabetes patients treated with empagliflozin (RECOVERY)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the association between the renoprotective effect of empagliflozin and companion diagnostics with urinary biomarkers in adult type 2 diabetes patients with mild or moderate renal dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the association between the concentration of urinary megalin and its ligand molecules such as alpha1-microglobulin and beta2-microglobulin and the change in renal function (eGFR)
Key secondary outcomes
1) The change in eGFR
2) Notable adverse effects (hypoglycemia, urinary tract, and genital infection, etc)
3) Serious adverse events (serious hypoglycemia, sepsis, hypovolemia, cerebral infarction, ischemic heart disease, ketoacidosis, acute kidney injury, and serious eruption, etc)
4) Other biomarkers such as urinary podocalyxin
5) Dietary evaluation using self-administered diet history questionnaire (DHQ)
6) Ambulatory blood pressure monitoring (ABPM)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To subscribe 10mg or 25mg/day empagliflozin (Jadiance) for 3 years
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those aged = or >20 and <80
2) HbA1c = or >6.5%
3) Type 2 diabetes mellitus patients with mild (60 = or < eGFR <90 mL/min/1.73m2) or moderate (30 = or <eGFR<60 mL/min/1.73m2) renal dysfunction
4) Those who can cope with dehydration
5) Those who can suspend taking medicine appropriately on sick days with fever, diarrhea, vomiting, or appetite loss
6) Those who have given written informed consent on the use of their data for the study
Key exclusion criteria
1) Those with past histories of hypersensitivity to SGLT2 inhibitors
2) Those with severe ketosis, diabetic coma or precoma
3) Those at perioperative stages, or those with severe infection or serious injury
4) Those with followings:
1. Hypopituitarism or adrenal insufficiency
2. Malnutrition, starvation, irregular or insufficient food intake, or debilitating condition
3. Excessive muscular exercise
4. Excessive alcohol drinker
5 ) Those with urinary tract or genital infection
6) Those with severe liver dysfunction
7) Those who are pregnant or hoping pregnancy
8) Those with a malignant tumor currently or in the past 5 years
9) Those who are treated currently with SGLT2 inhibitors
10) Those who are considered not eligible for the study by attending doctors because of any medical reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Saito |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL
025-227-0915
akisaito@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Saito |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL
025-227-0915
Homepage URL
akisaito@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
Tel
025-227-2006
shomu@med.niigata-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
新潟大学医歯学総合病院 (新潟県)、信楽園病院 (新潟県)、新潟臨港病院 (新潟県)、長岡赤十字病院 (新潟県)、長岡中央綜合病院 (新潟県)、立川綜合病院 (新潟県)、竹田綜合病院 (福島県)、佐渡総合病院 (新潟県)、えきまえクリニック内科はやし医院（(新潟県)、小千谷総合病院（新潟県）、済生会新潟第二病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 05 | 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
51
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Comparing before and after 3 months, urinary albumin tended to decrease from 247 +- 541 microg/gCr to 206 +- 398 microg/gCr, while urinary alpha1-microglobulin increased from 8.1 +- 8.4 mg/gCr to 11.9 +- 9.2 mg/gCr (P = 0.04).
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
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027514
