UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002515 |
|---|---|
| Receipt number | R000003074 |
| Scientific Title | Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload |
| Date of disclosure of the study information | 2009/09/24 |
| Last modified on | 2014/03/19 11:32:45 |
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Basic information
Public title
Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload
Acronym
Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload
Scientific Title
Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload
Scientific Title:Acronym
Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload
Region
| Japan |
Condition
Condition
Transfusion-induced iron overload
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating improvement of organ dysfunction (e.g. hematopoiesis, hepatic function, cardiac function, glucose intolerance) by iron chelation therapy with deferasirox.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluating hematopoietic improvement
Key secondary outcomes
Evaluating improvement of other organ dysfunctions (hepatic dysfunction, cardiac dysfunction, glucose intolerance), and validity of the "Japanese guidelines for the treatment of transfusional iron overload"
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are transfusion dependent and are expected to survive for >1 year.
Patients who have been transfused with >40 JPN units of pRBCs and/or whose serum ferritin levels are more than 1,000 ng/mL.
With wrriten informed consent
Key exclusion criteria
Patients with severe renal or hepatic dysfunction.
Patients who are pregnant or breastfeeding or expecting pregnancy.
Patients with history of hypersensitivity to deferasirox.
Patients who have been judged as inappropriate for any reasons by the concerning investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiya Ozawa |
Organization
Jichi Medical University
Division name
Division of Hematology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL
0285-58-7353
hematology@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Jichi Medical University
Division name
Division of Hematology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL
0285-58-7353
Homepage URL
hematology@jichi.ac.jp
Sponsor or person
Institute
The National Research Group on Idiopathic Bone Marrow Failure Syndromes in Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
自治医科大学附属病院（栃木県）、旭川医科大学（北海道）、その他全国施設
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate clinical course of laboratory tests, e.g. blood count, blood chemistry (including iron-related examinations).
Management information
Registered date
| 2009 | Year | 09 | Month | 17 | Day |
Last modified on
| 2014 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003074
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
