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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010952
Receipt No. R000012821
Scientific Title Effects of linagliptin on diabetic nephropathy in CKD patients
Date of disclosure of the study information 2013/06/13
Last modified on 2019/07/11

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Basic information
Public title Effects of linagliptin on diabetic nephropathy in CKD patients
Acronym Effects of linagliptin on diabetic nephropathy in CKD patients
Scientific Title Effects of linagliptin on diabetic nephropathy in CKD patients
Scientific Title:Acronym Effects of linagliptin on diabetic nephropathy in CKD patients
Region
Japan

Condition
Condition patients with diabetic nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of linagliptin on the progression of diabetic nephropathy in CKD patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes improvement of albuminuria
Key secondary outcomes improvement of GLP-1 activity, AGEs and glucose control

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 linagliptin
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diabetic nephropathy
Key exclusion criteria 1) diabetic ketoacidosis
2) severe infection
3) pregnancy
4) CHF, AKI
5) severe liver dysfunction
Target sample size 100

Research contact person
Name of lead principal investigator
1st name FUKAMI
Middle name
Last name KEI
Organization Kurume University School of Medicine
Division name Division of Nephrology, Department of Medicine,
Zip code 830-0011
Address 67 Asahi-machi
TEL 0942-35-3311
Email fukami@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Kei
Middle name
Last name Fukami
Organization Kurume University School of Medicine
Division name Division of Nephrology, Department of Medicine,
Zip code 830-0011
Address 67 Asahi-machi, Kurume city, Fukuoka
TEL 0942-35-3311
Homepage URL
Email fukami@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Department of Medicine, Kurume University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Division of Nephrology, Department of Medicine, Kurume University School of Medicine
Address 67 Asahi-machi
Tel +81942317002
Email fukami@med.kurume-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
2013 Year 06 Month 13 Day

Related information
URL releasing protocol non
Publication of results Unpublished

Result
URL related to results and publications non
Number of participants that the trial has enrolled 60
Results There was no evidence of the benefit of torazenta.
Results date posted
2019 Year 07 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics DN patients
Participant flow IN and OUT patients
Adverse events non
Outcome measures renal function proteinuria
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 03 Day
Date of IRB
2009 Year 06 Month 15 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 13 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012821

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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