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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007538
Receipt No. R000008907
Scientific Title A Safety and efficacy study of febuxostat, a non-purine-selective inhibitor of xanthine oxidase, for prevention of tumor lysis syndrome in patients with hematological malignancies.
Date of disclosure of the study information 2012/05/01
Last modified on 2021/01/04

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Basic information
Public title A Safety and efficacy study of febuxostat, a non-purine-selective inhibitor of xanthine oxidase, for prevention of tumor lysis syndrome in patients with hematological malignancies.
Acronym A Safety and efficacy study of febuxostat, a non-purine-selective inhibitor of xanthine oxidase, for prevention of tumor lysis syndrome in patients with hematological malignancies.
Scientific Title A Safety and efficacy study of febuxostat, a non-purine-selective inhibitor of xanthine oxidase, for prevention of tumor lysis syndrome in patients with hematological malignancies.
Scientific Title:Acronym A Safety and efficacy study of febuxostat, a non-purine-selective inhibitor of xanthine oxidase, for prevention of tumor lysis syndrome in patients with hematological malignancies.
Region
Japan

Condition
Condition Patients with hematological malignancies who develop tumor lysis syndrome
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of febuxostat use in patients with hematological malignancies developing tumor lysis syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Determine urate-lowering efficacy (the target urate level of 7.5 mg/dl) in patients developing tumor lysis syndrome.
Key secondary outcomes Safety in using febuxostat in patients with hematological malignancies developing tumor lysis syndrome.

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 febuxostat 60 mg/day orally
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with hematological malignancies who will receive chemotherapy and develop tumor lysis syndrome.
Key exclusion criteria impared hepatic function
renal dysfunction
diabetes mellitus
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Yamauchi
Organization University of Fukui
Division name Department of Hematology and Oncology
Zip code 910-1193
Address Matsuoka, Eiheiji
TEL +81776613111
Email tyamauch@u-fukui.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Yamauchi
Organization Univ. of Fukui
Division name Department of Hematology and Oncology
Zip code 910-1193
Address Matsuoka, Eiheiji
TEL +81776613111
Homepage URL
Email tyamauch@u-fukui.ac.jp

Sponsor
Institute Department of Hematology and Oncology, University of Fukui
Institute
Department

Funding Source
Organization Gout Research Foudation in Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Univ. of Fukui
Address 23-3 Matsuoka, Eiheiji, Fukui 910-1193
Tel +81776613111
Email tyamauch@u-fukui.ac.jp

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 05 Month 01 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/25503162/
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/25503162/
Number of participants that the trial has enrolled 10
Results The median S-UA at base-line was 8.0 mg/dl (range, 3.2-10.6 mg/dl). The median S-UA on day 5 after chemotherapy was 3.3 mg/dl (range, 1.1-5.8 mg/dl) (p<0.0001, by paired t test), indicating successful control of S-UA during chemotherapy. All patients achieved S-UA <7.5 mg/dl.
Results date posted
2021 Year 01 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2014 Year 12 Month 01 Day
Baseline Characteristics The patients with cancers and hyperuricemia.
Participant flow They received febuxostat as well as anticancer agents.
Adverse events No apparent adverse reactions were found.
Outcome measures The serum uric acid levels were determined mainly.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
2012 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 20 Day
Last modified on
2021 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008907

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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