UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011101
Receipt No. R000013001
Scientific Title The inhibitory effects of the DPP-4 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.
Date of disclosure of the study information 2013/08/01
Last modified on 2013/07/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The inhibitory effects of the DPP-4 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.
Acronym The inhibitory effects of the DPP-4 inhibitor for progression of diabetic nephropathy.
Scientific Title The inhibitory effects of the DPP-4 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.
Scientific Title:Acronym The inhibitory effects of the DPP-4 inhibitor for progression of diabetic nephropathy.
Region
Japan

Condition
Condition The CKD patients with type 2 diabetes
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of bood glucose change and renal function by DPP-4 inhibitor, for the CKD patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood glucose lowering effect ; HbA1c, 1,5-AG, GA
renal function ; u-L-FABP, UACR, eGFR, u-TGF-beta 1, u-Col IV
Key secondary outcomes lipid profile
oxidant stress
blood pressure, heart rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 vildagliptin 50mg-100mg
or sitagliptin 50mg-100mg
or alogliptin 12.5mg-25mg
or linagliptin 5mg
or teneligliptin 20mg-40mg
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) CKD patients with type 2 diabetes * HbA1c over 6.2%
2) patients with written informed consent
Key exclusion criteria 1) diabetic ketoacidosis, diabetic coma, type 1 diabetes
2) with severe liver dysfunction
3) severe infection, before and after surgery, severe trauma
4) end-stage renal failure during dialysis or severe renal dysfunction (CrCl under 30ml/min)
5) pregnant
6) patients with a history of hypersensitivity to any component of this drugs
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Koichi Kanozawa
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Nephrology and Hypertension
Zip code
Address Kamoda 1981, Kawagoe, Saitama
TEL 049-228-3604
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Koichi Kanozawa
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Nephrology and Hypertension
Zip code
Address Kamoda 1981, Kawagoe, Saitama
TEL 049-228-3604
Homepage URL
Email

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
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
Address
Tel
Email

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 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 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
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 Preinitiation
Date of protocol fixation
2013 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 02 Day
Last modified on
2013 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013001

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.