UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007538 |
|---|---|
| Receipt number | 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 09:00:21 |
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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
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
tyamauch@u-fukui.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008907
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