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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023902
Receipt No. 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 2019/09/05

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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
Email 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
Email akisaito@med.niigata-u.ac.jp

Sponsor
Institute Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email 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
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 No longer recruiting
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
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027514

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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