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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002515
Receipt No. 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

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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
Email 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
Email hematology@jichi.ac.jp

Sponsor
Institute The National Research Group on Idiopathic Bone Marrow Failure Syndromes in Japan
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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