UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032531 |
|---|---|
| Receipt number | R000037101 |
| Scientific Title | Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2022/04/01 15:26:49 |
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Basic information
Public title
Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension
Acronym
Investigator-initiated trial of repeated administration of NK-104-NP in patients with pulmonary hypertension
Scientific Title
Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension
Scientific Title:Acronym
Investigator-initiated trial of repeated administration of NK-104-NP in patients with pulmonary hypertension
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore effective and safety dose of NK-104-NP containing 2,4 or 8 mg pitavastatin calcium after 4 days repeated intravenous administration in patients with pulmonary arterial hypertension and examine pharmacokinetics in plasma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change of pulmonary vascular resistance (PVR) between baseline and day 84
Key secondary outcomes
Effectiveness: changes of following values between baseline and Day 84
Mean right atrial pressure (mPAP) at rest
Mean pulmonary arterial pressure (mPAP)
Cardiac output (CO)
Cardiac index (CI)
Pulmonary vascular resistance index (PVRI)
Total pulmonary resistance (TPR)
Mixed venous oxygen saturation (SvO2)
Distance of 6 minutes walk
Modified Borg index
WHO functional class
NT-proBNP concentration
NOx concentration
Total pulmonary resistance index(TPRI)
Systemic vascular resistance index (SVRI)
Pulmonary vascular resistance (PVR)
Safety: Incidences of following events
Adverse effects
Severe adverse effects
Side effect
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NK-104-NP 2 mg, 4 days
Interventions/Control_2
NK-104-NP 4 mg, 4 days
Interventions/Control_3
NK-104-NP 8 mg, 4 days
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with pulmonary hypertension classified as Dana Point group 1 and WHO functional class I to IV.
Idiopathic pulmonary arterial hypertension (IPAH)
Heritable pulmonary arterial hypertension (HPAH)
Drug or toxin-induced pulmonary hypertension
Pulmonary arterial hypertension associated with following diseases
a) Connective tissue diseases
b) Congenial heart diseases (at least 1 year has past after shunt repair at the baseline examinations)
c) HIV infection
2) Patients whose PAH is confirmed by right heart catheterization
Mean pulmonary arterial pressure (mPAP) at rest is over than or equal to 25 mmHg
Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure is under 15mmHg
3) Patients with over 240 dyn･sec/cm5 PVR at baseline right heart catherization
4) Patients treated with over 2 of 3 types of drugs (prostacyclin analogue, endothelin receptor antagonist, phosphodiesterase-5 inhibitor) and stable over 90 days
5) Over 20 and under 80 years old at the time of consent
Patients with a possibility of pregnancy must confirm their non-pregnant status before administration of NK-104-NP and agree to avoid pregnancy at least 180 days by secure contraception methods. Women with no possibility of pregnancy are defined as women who are post-menopausal state (no menses over 1 year, infertility or post-sterilization state).
6) Patients who have provided written informed consent with their signatures before procedures defined in the protocol.
Key exclusion criteria
1) Patients with malignancy or undergone surgeries due to malignancy within 5 years.
2) Patients taking statins and can NOT stop them from 3 days before administration of NK-104-NP.
3) Patients taking fibrates and can NOT stop them from 3 days before administration of NK-104-NP.
4) Patients taking cyclosporine.
5) Patients with severe cardiac dysfunction or heart failure (<30% ejection fraction or NYHA class III or over).
6) Patients with untreated severe arrhythmia except symptomatically stable patients with pacemaker or drug therapy.
7) Patients after prosthetic valve replacement (except biomaterials).
8) Patients with acute hepatitis, fulminant hepatitis or progressive liver dysfunction.
9) Patients with moderate or severe liver dysfunction (who can NOT satisfy following criteria) associated with chronic hepatitis etc. except patients with liver cirrhosis.
a) AST/ALT is within 3 times upper limit of shared reference range, b) serum bilirubin is 2 times upper limit of shared reference range.
10) Patients with liver cirrhosis and Child B(moderate) or C(severe) liver dysfunction.
11) Patients with obvious interstitial pneumonia.
12) Patients with biliary atresia.
13) Patients with CK(CPK) elevation over 3 times upper limit of shared reference range.
14) Patients with past-history of hypersensitivity or severe adverse effects by pitavastatin calcium.
15) Patients with severe drug allergy or adverse effects including anaphylactic shock.
16) Patients with alcohol abuse or drug addiction.
17) Patients in other trials at the time of informed consent or patients less than 16 weeks after termination of other test drugs.
18) Patients with pregnancy, patients with a possibility of pregnancy and breast-feeding women.
19) Patients judged to be inappropriate as a candidate of this trial by principal investigator or subinvestigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Egashira |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine
Zip code
830-0011
Address
67, Asahimachi, Kurume City, Fukuoka, 830-0011 JAPAN
TEL
0942-31-7563
koga.junichiro.853@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun-ichiro |
| Middle name | |
| Last name | Koga |
Organization
Kyushu University Hospital
Division name
Division of Angiocardiology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582 JAPAN
TEL
092-642-4649
Homepage URL
koga.junichiro.853@m.kyushu-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development (AMED)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
The University of Tokyo Hospital
Address
Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
Tel
03-5800-8743
IRBjimu-tokyo@umin.ac.jp
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
東京大学医学部付属病院、岡山大学病院、神戸大学医学部附属病院、久留米大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037101
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