UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008011 |
|---|---|
| Receipt number | R000009419 |
| Scientific Title | A Multicenter, Open-Label, Dose-Escalation, Investigator-Initiated Trial for 5-Day Repeated Intramuscular Administration of NK-104-NP to Treat Chronic Critical Limb Ischemia |
| Date of disclosure of the study information | 2012/05/31 |
| Last modified on | 2017/03/30 09:38:28 |
* 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
A Multicenter, Open-Label, Dose-Escalation, Investigator-Initiated Trial for 5-Day Repeated Intramuscular Administration of NK-104-NP to Treat Chronic Critical Limb Ischemia
Acronym
Administration of NK-104-NP to Treat Chronic Critical Limb Ischemia
Scientific Title
A Multicenter, Open-Label, Dose-Escalation, Investigator-Initiated Trial for 5-Day Repeated Intramuscular Administration of NK-104-NP to Treat Chronic Critical Limb Ischemia
Scientific Title:Acronym
Administration of NK-104-NP to Treat Chronic Critical Limb Ischemia
Region
| Japan |
Condition
Condition
Chronic critical limb ischemia associated with arteriosclerosis obliterans
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify doses showing safety and efficacy when NK-104-NP containing 0.5, 1, 2, and 4 mg of pitavastatin calcium is intramuscularly administered for 5 days repeatedly to patients with chronic critical limb ischemia, as well as to evaluate pharmacokinetics for the parent compound and the lactone bodies in plasma and urine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety: names, severity, and incidence rates of adverse events and adverse drug reactions
Pharmacokinetics: concentrations of pitavastatin and pitavastatin lactone in plasma and urine,
Efficacy: Fontaine classification and Rutherford classification
Key secondary outcomes
Safety: physiological tests (body weight, body temperature, blood pressure, and pulse), clinical laboratory tests, and cardiac function tests
Efficacy: ankle-brachial index (ABI) in the supine position, toe-brachial index (TBI) in the supine position, ankle pressure (AP) in the supine position, pulse volume recording (PVR), laser Doppler blood flow, angiography (IA-DSA), ulcer size, degree of pain (VAS), transcutaneous oxygen pressure (TcPO2), number of cases of minor amputation, number of cases of major amputation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NK-104-NP 0.5 mg/body
Interventions/Control_2
NK-104-NP 1 mg/body
Interventions/Control_3
NK-104-NP 2 mg/body
Interventions/Control_4
NK-104-NP 4 mg/body
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria before enrollment and who give written consent
1)Patients with Fontaine grades III or IV (generally ABI 0.90, TBI 0.60 or less)
2)Patients with difficulty in revascularization of the femoral artery or below, who do not show improvement in Fontaine classification with 2 weeks of drug therapy (vasodilatators, anti-platelet agents, or prostaglandins)
3)Patients aged 20 years or older at the time of consent
Key exclusion criteria
1) Rutherford grade 3 category 6
2)Malignant tumor or patients who underwent malignant tumor operation within the past 5 years
3)Patients scheduled for surgery for ulcers caused by chronic critical limb ischemia
4)Patients who used anticoagulants within 3 days before starting the administration of the test product.
5)Patients taking a statin.
6)Patients taking a fibrate
7)Patients taking ciclosporins
8)Patients with severe cardiac function disturbance or heart failure
9)Patients with untreated severe arrhythmias
10)Patients with a history of prosthetic valve replacement
11)Patients with progressive hepatic dysfunction
12)Patients with moderate or severe hepatic dysfunction associated with chronic hepatitis.
13)Patients diagnosed with hepatic cirrhosis of Child score B or C
14)Patients with clear findings of interstitial pneumonia
15)Patients with biliary obstruction
16)Patients with a CK high level
17)Patients with a history of hypersensitivity or a serious adverse drug reaction to pitavastatin calcium
18)Patients with a history of serious drug allergy
19)Patients with alcohol dependence or drug dependence
20) others
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Furuyama |
Organization
Kyushu University Hospital
Division name
Department of Surgery and Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
81-92-642-6919
kaku@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Furuyama |
Organization
Kyushu University Hospital
Division name
Kyushu University Graduate School of Medical Sciences
Zip code
Address
3-1-1 Maidashi, Higashi-ku,Fukuoka
TEL
81-92-642-6789
Homepage URL
kaku@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science & Technology in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
九州大学病院（福岡県）、名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 31 | 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 | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009419
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
