UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007718 |
|---|---|
| Receipt number | R000009096 |
| Scientific Title | Anti-platelet therapy for prevention of diabetic nephropathy |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2016/02/23 18:45:16 |
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Basic information
Public title
Anti-platelet therapy for prevention of diabetic nephropathy
Acronym
ATP-DN
Scientific Title
Anti-platelet therapy for prevention of diabetic nephropathy
Scientific Title:Acronym
ATP-DN
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Investigate the effect of antiplatelets (cilistazol) for prevention of diabetic nephropathy by multicenter, randomized, double blind, placebo-controlled, dose comparative study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Urine albumin creatinine ratio (ACR) (a geometric mean of 2nd continuation)
Key secondary outcomes
<Efficacy>
eGFR, serum cystatin C, and serum high molecular weight adiponectin
<Safety>
(1) Influence to diabetes and diabetic nephropathy (significant increase of HbA1c, ACR and decrease of eGFR)
(2)Comparison of adverse effects (containing change of laboratory data)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
OPC-13013 placebo: administration for 12 weeks
Interventions/Control_2
OPC-13013 100 mg: administration for 12 weeks
Interventions/Control_3
OPC-13013 200 mg: administration for 12 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetes mellitus outpatients, no limitation of treatment.
2) Ranging in age from 20 to 75 years at informed consent.
3) Diabetic nephropathy, stage III (serum CRE < 2.5 mg/dl and ACR>300 mg/g CRE at visit 2)
4) HbA1c (NGSP) < 9.4% at visit 2.
5) Blood pressure < 160/100 mmHg at visit 2.
6) Patient administrated with renin-angiotensin system inhibitors for more than three months.
During this trial, addition and change of renin-angiotensin system inhibitors are not permitted in principle. Kinds of other anti-hypertensive drug were not limited.
7) No limitation for administration of anti-platelets excepting dipyridamole.
Dipyridamole should be stopped at the day more than 28 days before visit 3, or changed to other antiplatelets at informed consent.
Patient treated with other antiplatelets must be administrated for more than 3 months and addition and change of them are not permitted during this trial.
Key exclusion criteria
1) The patient who has hypersensitivity to cilostazol.
2) Contraindication of cilostazol (patients with bleeding and congestive heart failure).
3) The patient administrated cilostazol previously (since possibility to have an influence on the efficacy and the safety).
4) The patient administrated dipyridamole at informed consent and has difficulty for interruption.
5) Tachycardia (heart rate > 100/min) in ECG at visit 2.
6) Severe liver dysfunction (more than 3 times of the standard value upper limit of AST, ALT, -GTP) an visit 2
7) Hb < 9g/dl at visit 2.
8) Pregnant or pregnantpossibility.
9) The patient who has malignancy or previous history of malignancy (however, patient, who is unnecessary of treatment, no recurrence, and become no recurrence during trial, can participate)
10) The patient who has previous history of bleeding, was under treatment of bleeding, or has active diabetic retinopathy.
11) The patient who has the following diseases at Visit2.
Chronic urinary tract infection
Neurogenic bladder
Nephritis or suspect
Renal disease excepting diabetic nephropathy (chronic glomerulonephritis, polycystic kidney disease, etc.)
12) The patient administrated CYP3A4 inhibitors (macrolide antibiotic, HIV protease inhibitor, azole antifungals, cimetidine, Diltiazem hydrochloride, etc) (since the pharmacodynamics of cilostazole in vivo will affect the evaluation of dose-reaction relationship)
13) The patient who had participated trials of other unrecognized pharmaceutical products or medical device in the past 30 days.
14) The patient judged to be inadequacy by the attending physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Seki, M.D. |
Organization
National Hospital Organization, Chiba-East National Hospital
Division name
Clinical Research Center, Laboratory of Diabetes Mellitus
Zip code
Address
673 Nitona, Chuo-ku, Chiba City, Chiba, 260-8712, Japan
TEL
043-261-5171
sekinao@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Seki, M.D. |
Organization
National Hospital Organization Chiba-higasi Hospital
Division name
Clinical Research Center
Zip code
Address
673, Nitona-cho, Chiba-city, Chiba, 260-0712, Japan
TEL
043-261-5171(2740)
Homepage URL
https://www.nhocrc.jp/index.html
imitsuno@hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Headquarters
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Headquarters
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
独立行政法人国立病院機構旭川医療センター（北海道）
独立行政法人国立病院機構埼玉医療センター（埼玉県）
独立行政法人国立病院機構千葉東病院（千葉県）
独立行政法人国立病院機構横浜医療センター（神奈川県）
独立行政法人国立病院機構まつもと医療センター松本病院（長野県）
独立行政法人国立病院機構静岡医療センター（静岡県）
独立行政法人国立病院機構三重中央医療センター（三重県）
独立行政法人国立病院機構京都医療センター（京都府）
独立行政法人国立病院機構大阪医療センター（大阪府）
独立行政法人国立病院機構浜田医療センター（島根県）
独立行政法人国立病院機構岡山医療センター（岡山県）
独立行政法人国立病院機構東広島医療センター（広島県）
独立行政法人国立病院機構小倉医療センター（福岡県）
独立行政法人国立病院機構九州医療センター（福岡県）
独立行政法人国立病院機構嬉野医療センター（佐賀県）
独立行政法人国立病院機構別府医療センター（大分県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 10 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009096
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| Registered date | File name |
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| Registered date | File name |
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