UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007644 |
|---|---|
| Receipt number | R000009016 |
| Scientific Title | A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload |
| Date of disclosure of the study information | 2012/04/03 |
| Last modified on | 2018/10/08 00:07:56 |
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Basic information
Public title
A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Acronym
A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Scientific Title
A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Scientific Title:Acronym
A prospective study of treatment continuation rate with early low-dose iron chelation therapy for 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
We consider whether it is possible to increase the treatment continuation rate by initiating the early low-dose iron chelation therapy in patients with transfusion-induced iron overload.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Treatment continuation rate at 12 months after the initiation of iron chelation therapy
Key secondary outcomes
(1) Changes of serum ferritin
(2) Achievement rate of SF<1,000
(3) Achievement rate of SF<2,500
(4) Improvement of organ failure (heart, liver, pancreas)
(5) Safety
(6) Hematopoietic improvement (IWG2006 criteria)
(7) total dose of transfusions
(8) Concentration of EPO
(9) Exposure of deferasirox
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
Iron chelation therapy is performed early in patients with
transfusion-induced iron overload.
Iron chelation therapy is to start from low-dose administration at the discretion of the attending physician.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have required two units or more red cell transfusion a month.
(2) 500<=SF<=2,500
(3) aged 16 and over
(4) Patients who had not received deferasirox.
(5) Patients with an ECOG performance status of 0-1
(6) Patient who gave written informed consent before starting the screening test (by both a patient and a legal representative if a patient is minor).
Key exclusion criteria
(1) Patients with simultaneous multiple cancers.
(2) Patients with severe liver or severe renal dysfunction.
(3) Pregnant women or those with suspected pregnancy or nursing women
(4) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study.
(5) Patients with history of hyper sensitivity to deferasirox.
(6) Patients with history of hematopoietic stem cell transplantation.
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensuke Ohta |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Division of Hematology
Zip code
Address
2-10-39,Shibata,Kita-ku,Osaka,Japan
TEL
(06)6372-0333
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Yamamura |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Division of Hematology
Zip code
Address
2-10-39,Shibata,Kita-ku,Osaka,Japan
TEL
(06)6372-0333
Homepage URL
yamamura@nakatsu.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 03 | 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
| 2012 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009016
