UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007840 |
|---|---|
| Receipt number | 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 20:57:19 |
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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
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
sumytany@nifty.com
Sponsor or person
Institute
Osaka City General Hospital
Department of Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009242
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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