UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018464 |
|---|---|
| Receipt number | R000007342 |
| Scientific Title | Efficacy and safety of DPP-4 inhibitors in patients with chronic kidney disease |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2015/07/29 10:57:09 |
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Basic information
Public title
Efficacy and safety of DPP-4 inhibitors in patients with chronic kidney disease
Acronym
DPP-4 inhibitors for CKD
Scientific Title
Efficacy and safety of DPP-4 inhibitors in patients with chronic kidney disease
Scientific Title:Acronym
DPP-4 inhibitors for CKD
Region
| Japan |
Condition
Condition
Diabetic nephropathy and chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the efficacy and safety of DPP-4 inhibitors for patients with diabetic nephropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemoglobin A1c level, glycated albumin level, postprandial plasma glucose level
Key secondary outcomes
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
sitagliptin
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 stage 1-3
2) more than 20 years old and less than 80 tears old
3) HbA1c level more than 7.0% and less than 10% at baseline
Key exclusion criteria
1) CKD stage 4, 5, and 5D
2) less than 20 years old and more than 80 years old
3) Subjects who were treated with steroid
4) Liver dysfunction
5) Subjects who had malignant tumor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Maruyama |
Organization
Nihon University Nerima Hikarigaoka Hospital
Division name
Internal Medicine
Zip code
Address
2-11-1, Hikarigaoka, Nerima-ku, Tokyo, Japan
TEL
03-3972-8111
maruyama.noriaki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Abe |
Organization
Nihon University School of Medicine
Division name
Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
TEL
03-3972-8111
Homepage URL
mabe@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 28 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007342
