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 UMIN000010261
Receipt No. 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

* 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 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
Email

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
Email youko.n@med.kagawa-u.ac.jp

Sponsor
Institute Faculty of Medicine, Kagawa University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012010

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.