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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026847
Receipt No. R000029056
Scientific Title Urate lowering drugs RandomIzed parallel-group Comparison study in the Chronic Kidney Disease patients with hypertension and hyperuricemia
Date of disclosure of the study information 2017/04/10
Last modified on 2020/05/15

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Basic information
Public title Urate lowering drugs RandomIzed parallel-group Comparison study in the Chronic Kidney Disease patients with hypertension and hyperuricemia

Acronym URIC-CKD study
Scientific Title Urate lowering drugs RandomIzed parallel-group Comparison study in the Chronic Kidney Disease patients with hypertension and hyperuricemia

Scientific Title:Acronym URIC-CKD study
Region
Japan

Condition
Condition Chronic kidney disease with hyperuricemia and hypertension
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of xanthine oxidase inhibitor and urate transporter 1 inhibitor on the renal dysfunction in chronic kidney disease patients with hyperuricemia and hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rate of change in estimated GFR from baseline to 52 week (%/52week and ml/min/1/73m2/52w)
Key secondary outcomes 1) Rate of change in eGFR from the baseline to 8 weeks
2) Rate of change in office blood pressure from the baseline to 8 and 52 weeks
3) Difference in rate of change in estimated GFR before(Visit 1 to 2) and after treatment (Visit 2 to 4)
4) Rate of change in serum uric acid from baseline to 8 and 52 weeks and achievement rate of serum uric acid concentration less than 6 mg/dl at 8 and 52 weeks
5) Rate of change in urinary albumin-to-creatine ratio from baseline to 8 and 52 weeks
6) Rate of change in urinary pH from baseline to 8 and 52 weeks
7) Rate of change in serum xanthine oxidase activity from baseline to 8 and 52 weeks
8) Rate of change in high sensitive C reactive protein from baseline to 8 and 52 weeks
9) Rate of change in 8-OHdG (8-hydroxy-2-deoxyguanosine) from baseline to 8 and 52 weeks
10) Rate of change in urinary angiotensinogen from baseline to 8 and 52 weeks
11) Rate of change in L type free fatty acid binding protein(L-FABP) from baseline to 8 and 52 weeks
12) Rate of change in estimated GFR from baseline to 52 weeks stratified by basal urinary albumin-to-creatinine ratio (300mg/gCr) or estimated GFR (45ml/min/1.73m2)


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Febuxostat group:
Patients take febuxostat by oral administration for 52 weeks (approximately one year).
The beginning dosage of the febuxostat is 10 mg/day. The dose is increased to 20 mg /day after four weeks and is maintained until 8 weeks. The dose will be titrated to maintain serum uric acid levels less than 6mg/dl after 8 weeks until the 52 weeks.
Interventions/Control_2 Benzbromarone group:
Patients take benzbromarone by oral administration for 52 weeks (approximately one year).
The beginning dosage of the benzbromarone is 25 mg/day and is maintained for 8 weeks. The dose will be titrated to maintain serum uric acid levels less than 6 mg/dl after 8 weeks until the 52 weeks. Alkalization of urinewill be initiated if urine is acidic.
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 1) Serum uric acid >7.0 mg/dL
2) Patients with hypertension defined as blood pressure measurements of equal or more than 140 mm Hg systolic and/or equal or more than 90 mm Hg diastolic or treatment with antihypertensive agents. No changes in prescription of antihypertensive agent 8 weeks before initiating the study drug.
3) CKD stage 3a and 3b
4) Age equal to or more than 20 years at obtaining informed consent
5) Outpatient
6) No history of gout
7) Obtained written informed consent from the patient for participation to the study
Key exclusion criteria 1) History of hypersensitivity to febuxostat or benzbromarone
2) AST or ALT is more than twice the upper limit of institutional normal range
3) eGFR <30ml/min/1.73m2 or dialysis patients.
4) Under treatment with thiazide diuretics or loop diuretics
5) History of treatment with urate lowering drugs within 2 weeks before determination of eligibility
6) History of coronary heart disease within 3 month before determination of eligibility
7) Patients with neoplasm, History of neoplasm except for the cured patients without recurrence within 5 years before determination of eligibility
8) Under treatment with the following: mercaptopurine,azathioprine, pyrazinamide, ethanbutol
9) Under treatment with warfarin
10) Women who are or may be pregnant, or brest-feeding
11) Participants of other clinical trials within 6 month before determination of eligibility
12) Urolithiasis
13) A patient who are judged inadequate for enrollment by an attending physician
14) A patient whose serum uric acid level is equal to or less than 7 mg/dl at Visit2 after randomization
15) A patient has been suffered from any of following: acute myocardial infarction, acute coronary syndrome, patients undergoing percutaneous coronary intervention or coronary artery bypass grafting, vetricular tachycarida, mutifocal ventricular arrhythmia and acute heart failure within three months before the eligibility assessment. This exclusion criteria was added since recent study suggested febuxostat may be associated with increased cardiovascular mortality compared with allopurinol among gout patients with major cardiovascular disease (N Engl J Med 2018;378:1200-10)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Kohagura
Organization University hospital of the Ryukyus
Division name Dialysis Unit
Zip code 9030215
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL 0988951341
Email kohagura@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Kohagura
Organization University hospital of the Ryukyus
Division name Dialysis Unit
Zip code 9030215
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL 0988951341
Homepage URL
Email kohagura@med.u-ryukyu.ac.jp

Sponsor
Institute Dialysis Unit, University Hospital of the Ryukyus
Institute
Department

Funding Source
Organization TEIJIN Pharma, Co,insp
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 Review Board of University of the Ryukyus for Clinical Research
Address 1 Senbaru, Nishihara-cho, Nakagami-gun, Okinawa, Japan
Tel 098-895-8016
Email knknkyu@to.jim.u-ryukyu.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 琉球大学医学部附属病院、南部病院、海邦病院、首里城下町クリニック、中頭病院

Other administrative information
Date of disclosure of the study information
2017 Year 04 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 88
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
2016 Year 11 Month 16 Day
Date of IRB
2015 Year 11 Month 18 Day
Anticipated trial start date
2017 Year 11 Month 18 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 03 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029056

Research Plan
Registered date File name
2018/12/11 3)1002【9.0版】②実施計画書2018.6.27(血液浄化療法部%E3%80%80古波蔵).docx

Research case data specifications
Registered date File name
2018/04/06 中止報告書.pdf

Research case data
Registered date File name


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