UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011101 |
|---|---|
| Receipt number | 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 23:52:09 |
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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
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
Public contact
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
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013001
