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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041322
Receipt No. R000047173
Scientific Title Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Date of disclosure of the study information 2020/08/10
Last modified on 2021/04/06

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Basic information
Public title Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Acronym Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Scientific Title Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Scientific Title:Acronym Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Region
Japan

Condition
Condition The analysis data set of the main trial will be used as the database of this study.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine in greater detail the protective effect of febuxostat against vascular damage by patient background and pathology, and to elucidate from various perspectives the efficacy and safety of febuxostat when used for the treatment of hyperuricemia through examination of organ-related effects of febuxostat and the relationship with other clinical indicators obtained in this study, by conducting the sub-studies (as described below) of the program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (hereinafter referred to as main trial), which was conducted from January 2014 through March 2019.

Specifically, in the sub-studies, the impact of febuxostat on flow-mediated dilation (FMD), pulse wave velocity (PWV), the cardio ankle vascular index (CAVI), IMT, echocardiography, etc., as well as the relationship between febuxostat and other clinical indicators (uric acid level, etc.) will be evaluated. In addition, the impact of febuxostat on exploratory biomarkers, etc., associated with the remodeling of cardiac and renal disorders and the progression of dysfunction, the efficacy and safety of febuxostat in patients with chronic kidney disease (CKD), and the impact of fluctuations in blood pressure on the progression of arteriosclerosis will be examined. Moreover, a more detailed stratified analysis will be conducted by clinical setting and administered dose of febuxostat, and by using such indicators as the uric acid level. By doing these, the efficacy and safety of febuxostat regarding various clinical indicators such as carotid IMT and uric acid level-that have not been analyzed in detail yet although data on these have already been obtained at the main trial-will be analyzed, with the goal of elucidating the effect of febuxostat on hyperuricemia from various perspectives.
Basic objectives2 Others
Basic objectives -Others Examination of the impact of febuxostat on FMD,carotid plaque echolucency,
IMT,cardiac function,hepatic function, MDA-LDL ,kidneys,biomarkers, and lipids.
Examination for the elucidation of carotid IMT progression factors.Examination of the impact of fluctuations in blood pressure on the progression of arteriosclerosis.Examination of the impact of febuxostat on vascular functions hardness of arteries based on blood-pressure levels and the presence or absence of hypertension and renal impairment.Examination of the impact of febuxostat on carotid IMT based on vascular functions.Examination of the relationship between uric acid and vascular function/ sRAGE.Examination of the impact on carotid IMT by febuxostat dose.Examination of the impact on carotid IMT by uric acid level.Examination of predictive factors of MACE.Examination of the quality of trial data obtained in multicenter studies.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rate of change from baseline after 24 months in the mean IMT value of the common carotid artery determined by carotid artery ultrasound
Key secondary outcomes 1. IMT, FMD, PWV, CAVI, EF, LVEF, E, A, TRPG, e' and E/e' by treatment group at each measurement point
2. Blood test values (red blood cells, white blood cells, hemoglobin, hematocrit, blood platelet count, AST, ALT, LDH, BUN, Na, K, Cl, blood glucose, serum uric acid level, serum lipids: TC, HDL-C, TG, non-HDL-C, LDL-C, serum creatinine, eGFR), serum biomarker values NT-proBNP, high-sensitivity CRP, 1, 5AG, small dense LDL, RLP-C, MDA-LDL, serum cystatin C, RAGE, high-molecular adiponectin, high-sensitivity troponin I, ANGPTL2, Alb, Ca, FGF23, P), and urine test values (urinary albumin excretion, urinary L-FABP) by treatment group at each measurement point

Base
Study type Others,meta-analysis etc

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 The analysis data set of the main trial will be used as the database of this study.
Number of cases in the database:
Febuxostat group: 239 cases
Control group: 244 cases
Key exclusion criteria Not applicable
Target sample size 483

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Node
Organization Saga University
Division name Department of Cardiovascular Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2364
Email cardiostudy@ml.cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Tanaka
Organization Saga University
Division name Department of Cardiovascular Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2364
Homepage URL
Email cardiostudy@ml.cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

Funding Source
Organization TEIJIN PHARMA LIMITED
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 Clinical Research Center,Saga University Hospital
Address 5-1-1 Nabeshima, Saga
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-u.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 佐賀大学

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 10 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 483
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 No longer recruiting
Date of protocol fixation
2020 Year 05 Month 26 Day
Date of IRB
2020 Year 07 Month 22 Day
Anticipated trial start date
2020 Year 08 Month 04 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The analysis data set that was obtained in the main trial will be used as the database of this study.

Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor , febuxostat : multicenter , randomized controlled study

Management information
Registered date
2020 Year 08 Month 05 Day
Last modified on
2021 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047173

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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