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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007840
Receipt No. R000009242
Scientific Title A clinical trial to evaluate iron preparation effect for the pulmonary hypertension secondary in chronic respiratory disease patients
Date of disclosure of the study information 2012/04/26
Last modified on 2014/02/28

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Basic information
Public title A clinical trial to evaluate iron preparation effect for the pulmonary hypertension secondary in chronic respiratory disease patients
Acronym Secondary PH-Fe study
Scientific Title A clinical trial to evaluate iron preparation effect for the pulmonary hypertension secondary in chronic respiratory disease patients
Scientific Title:Acronym Secondary PH-Fe study
Region
Japan

Condition
Condition Chronic respiratory failure patients with pulmonary arterial hypertension
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Chronic respiratory failure patients with pulmonary hypertension receive iron preparation load and we examine short-term effect to pulmonary arterial pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes TR-PG level by the heart ultrasonography
Key secondary outcomes PaO2 level, reticulocyte count, NT-pro BNP level, hematocrit, mean concentration hematocrit (MCH), mean corpuscular hemoglobin concentration (MCHC)

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 infusion by saccharatedferric oxide
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Chronic respiratory failure patients
2.Less than Hb 16mg/dl
3.Lower than ferritin level 500ng/ml
4.TR -PG level is more than 32torr in heart ultrasonography findings
5.Age is 60 years old or older
6.Patients receive enough explanation about this study, and patients who provide their written informed consent to participate in this study.
Key exclusion criteria 1.Patient's fever is 38 degrees or more within one week before screening test
2.Patients complicated with active tuberculosis and atypical mycobacterial disease
3.Patients with active respiratory tract infection in chest Xp or clinical examination
4.Patients with active heart failure with the hemostatic findings in chest Xp
**But, we make it possible to conduct a screening test after hemostatic findings disappeared in case that recognized hemostatic findings in chest X-rays.
5.Patients with pneumothorax in chest Xp
6.Patients with pleural effusion that drainage needs
7.Patients with history of hypersensitivity with iron preparation formulation
8.Patients who are complicated with apparent hepatic cirrhosis or active hepatitis
9.Patients with history of paroxysmal nocturnal hemoglobinemia
10.Patients with apparent renal failure
11.The patients in acknowledgment of exacerbation with existing illness within one month from screening test
12.A pregnant woman or the patients with the possibility to become pregnant and nursing patients
13.In addition, the patients whom doctor attending judged to be inadequate as a study candidate
Target sample size 41

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Sumitani
Organization Osaka City Gerenal Hospital
Division name Respiratory Medicine
Zip code
Address 2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka
TEL 06-6929-1221
Email sumytany@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Sumitani
Organization Osaka City Gerenal Hospital
Division name Respiratory Medicine
Zip code
Address 2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka
TEL 06-6929-1221
Homepage URL
Email sumytany@nifty.com

Sponsor
Institute Osaka City General Hospital
Department of Respiratory Medicine
Institute
Department

Funding Source
Organization Osaka City General Hospital
Department of Respiratory Medicine
Organization
Division
Category of Funding Organization Self funding
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 伊勢赤十字病院(三重県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 26 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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 26 Day
Last modified on
2014 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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