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Recruitment status Completed
Unique ID issued by UMIN UMIN000008011
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email kaku@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute AMED
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009419


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