UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010261 |
|---|---|
| Receipt number | R000012010 |
| Scientific Title | Multi-center cooperative clinical study on the renoprotective effect of DPP-4 inhibitor (Vildagliptin) in Diabetic nephropathy patients |
| Date of disclosure of the study information | 2013/03/25 |
| Last modified on | 2013/03/17 15:33:06 |
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Basic information
Public title
Multi-center cooperative clinical study on the renoprotective effect of DPP-4 inhibitor (Vildagliptin) in Diabetic nephropathy patients
Acronym
Clinical study on the renoprotective effect of DPP-4 inhibitor (Vildagliptin) in Diabetic nephropathy patients
Scientific Title
Multi-center cooperative clinical study on the renoprotective effect of DPP-4 inhibitor (Vildagliptin) in Diabetic nephropathy patients
Scientific Title:Acronym
Clinical study on the renoprotective effect of DPP-4 inhibitor (Vildagliptin) in Diabetic nephropathy patients
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the renoprotective effect (by changes in eGFR and urinary albumin) of new or additional doses of Vildagliptin in type 2 Diabetic nephropathy patients who are under a diet/exercise treatment or other medical treatment and still show insufficient glycemic control.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in HbA1c (NGSP) value at 12 weeks after administration.
Changes in eGFR and urinary albumin level at 12 weeks after administration.
Key secondary outcomes
(Only in patients who give consent)
Changes in fasting or 1~2-hour-postprandial blood glucose concentration.
Changes in urinary protein at 12 weeks after administration.
Changes in the following biomarkers at 12 weeks after administration. (urinary 8-OHdG, plasma/urinary Angiotensinogen, urinary NGA, glycoalbumin only at eligible institutions)
Changes in 24-hour blood pressure at 24 weeks after administration.
Adverse events are to be investigated by doctors' oral consultation.
Evaluation of the effectiveness and the safety of Vildagliptin .
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
Type 2 diabetic patients with HbA1c more than 6.9% and less than 10.0% (NSGP value) having been under a diet/exercise treatment or under treatment of a same hypoglycemic agent for at least three months or more.
Vildagliptin 50 mg is to be administered orally twice a day, once in the morning and once in the evening. Depending on the patient's condition, 50 mg may be administered only once a day in the morning.
Observation period for 4 weeks, and drug administration period for 24 weeks, totaling 28 weeks of duration.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 Diabetic nephropathy patients who do not show sufficient therapeutic effects by any of the following treatments.
They should meet all the standards shown below.
1) HbA1c is more than 6.9% and less than 10.0% (NSGP value)
2) Under a diet/exercise treatment or medical treatment for at least three months or more. The kind of the oral hypoglycemic agent used is not asked.
The patient should be administered with a same Sulfonylurea, if any, at the dosage less than the daily dose shown below for three months or more.
# 2.5 mg/day for Glibenclamide
# 60 mg/day for Gliclazide
# 3 mg/day for Glimepiride
3) eGFR is more than 50 ml/min.
Key exclusion criteria
1) Patients with contraindications for Vildagliptin
2) Patients participating in other clinical trials
3) Women during pregnancy, after childbirth, on breastfeeding, or with the possibility of being pregnant.
4) Patients with other severe complications
5) Patients judged inadequate for other reasons by doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Kohno |
Organization
Faculty of Medicine, Kagawa University
Division name
Cardiorenal and Cerebrovascular Medicine
Zip code
Address
1750-1, Ikenobe, Miki, Kita, Kagawa
TEL
087-898-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Nishijima |
Organization
Faculty of Medicine, Kagawa University
Division name
Cardiorenal and Cerebrovascular Medicine
Zip code
Address
1750-1, Ikenobe, Miki, Kita, Kagawa
TEL
087-898-5111
Homepage URL
youko.n@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shionoe Branch of Takamatsu Municipal Hospital
Takamatsu Medical Center
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
香川大学医学部附属病院（香川県）、高松市民病院 塩江分院（香川県）、高松医療センター（香川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 25 | 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 | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2015 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2013 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012010
