UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020939 |
|---|---|
| Receipt number | R000024159 |
| Scientific Title | The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA : A (Prospective) Randomized Controlled Clinical Trial of Topiroxostat and Alloprinol |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2020/03/12 09:47:13 |
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Basic information
Public title
The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA : A (Prospective) Randomized Controlled Clinical Trial of Topiroxostat and Alloprinol
Acronym
The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA (Excite-UA study)
Scientific Title
The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA : A (Prospective) Randomized Controlled Clinical Trial of Topiroxostat and Alloprinol
Scientific Title:Acronym
The Effect of Xanthine Oxidase Inhibitor in ChronIc heart failure patients complicaTED with hyper-UricemiA (Excite-UA study)
Region
| Japan |
Condition
Condition
Hyperuricemia with heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of topiroxostat and allopurinol on heart and endothelial functioning among patients with hyperuricemia complicated with heart heart failure
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change in NT-proBNP from baseline to the 24th week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:
administering topiroxostat with minimum amount of 20 mg twice a day (after breakfast), and gradually increase the amount every four weeks aiming for blood uric acid level 6.0 mg/dL or lower
Dosage per day can be increased up to 160 mg/day, and keep the dosage during the study
The dosage is decreased one level (20 mg) when uric acid level is at 20 mg/dL or lower
Interventions/Control_2
Group B: administering allopurinol, starting with 100 mg once a day as a minimum dose (after breakfast)
Dosage is not increased when eGFR is below 50 ml/min/1.73 square meters (or CCr 50 ml/min)
Dosage is increased every 4 weeks, from 100 mg per day to 100 mg twice a day, and 100 mg three times a day aiming for blood uric acid 6.0 mg/dL, when eGFR is 50 ml/min/1.73 square meters (or CCr 50 ml/min) or above
The dosage is decreased one level (20 mg) when uric acid level is at 20 mg/dL or lower
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included in this study.
1. Patients with hyperuricemia (untreated with uric acid level 7.0 mg/dl or above, or currently on medication) with a history of heart failure (however BNP is 40 pg/ml or above according to the Japan Heart Failure Society)
2. Not using any medication for hyperuricemia for more than four weeks before the study
3. Being able to provide written informed consent
4. 20 years of age or older, and younger than 85 years of age at time of providing their written informed consent
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study.
1.Have a history of hypersensitivity to the test drug
2.Currently on medication of mercaptopurine hydrate or azathioprine
3.Currently have a severe liver failure (AST or ALT level is doubled from the standard values provided by each hospital/clinic)
4.Complicated with chronic liver disease, malignant tumor, active infection, or inflammatory disease
5.Currently have gout arthritis or the disease is cured for less than two weeks
6.Currently have nephrolithiasis or on treatment
7.eGFR is below 30 ml/min/1.73 square meters (CCr 30ml/min)
8.Currently have acute heart failure
9.After acute exacerbation improvement in chronic heart failure is less than two weeks
10. Currently pregnant or possibly conceived a child, or brest feeding
11.Other conditions that physicians judge to be inappropriate to be in the study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Inoue |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
321-0207
Address
880 Kitakobayashi Mibu-cho Simotsuga-gun, Tochigi Japan
TEL
0282-87-2146
inouet@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
101-0052
Address
NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Dokkyo Medical University
Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Sanwa Kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Dokkyo Medical University School of Medicine
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
| 2016 | Year | 02 | Month | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024159
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