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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026741
Receipt No. R000030011
Scientific Title A trial to examine the effect of intensive UA-lowering therapy in patients with CKD and hyperuricemia
Date of disclosure of the study information 2017/03/28
Last modified on 2019/06/06

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Basic information
Public title A trial to examine the effect of intensive UA-lowering therapy in patients with CKD and hyperuricemia
Acronym A trial to examine the effect of intensive UA-lowering therapy in patients with CKD and hyperuricemia(TARGET-UA)
Scientific Title A trial to examine the effect of intensive UA-lowering therapy in patients with CKD and hyperuricemia
Scientific Title:Acronym A trial to examine the effect of intensive UA-lowering therapy in patients with CKD and hyperuricemia(TARGET-UA)
Region
Japan

Condition
Condition Patients with CKD and hyperuricemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes in urinary albumin-to-creatinine ratio
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: Intensive therapy group with Topiroxostat
Target serum uric acid level: 4.0 mg/dL to 5.0 mg/dL
The treatment period: 12 months
Maximum usage of Topiroxostat is 160 mg per day.
Interventions/Control_2 Group B: Standard therapy group with Topiroxostat
Target serum uric acid level: 6.0 mg/dL to 7.0 mg/dL
The treatment period : 12 months
Maximum usage of Topiroxostat is 160 mg per day.
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 Including criteria
1.Patinets aged 20 years and older
2.Stage 3 CKD patients(30<=eGFR<60 ml/min/1.73m2)whose urinary protein excretion is less than 0.5g/gCre or urinary albumin excretion is less than 300mg/gCre.
3.Patients whose serum uric acid level is higher than 8.0 mg/dl,
or patients with allopurinol and/or benzbromarone whose serum uric acid level is higher than 7.0 mg/dl
Key exclusion criteria Excluding criteria
1. History of hypersensitivity to topiroxostat
2. Being treated with either febuxostat or topiraxostat
3. History of repeated gouty arthritis attack
4. History of attacks of urinary stone within 6 months
5. Obstructive urinary tract disorders
6. Primary or secondary hyperuricemia (congenital myogenic hyperuricemia, hematopoietic tumor, solid tumor, secondary polycythemia, hemolytic anemia, tumor lysis syndrome, rhabdomyolysis, multiple sclerosis, multiple juvenile gout nephropathy, polycystic kidney etc.)
7. active malignancy
8. Severe hepatic dysfunctions (transaminase >= 100 IU / L)
9. Poorly controlled diabetes mellitus (HbA1c> 8.4%)
10. Severe hypertension (sBP >= 180 mm Hg or dBP >= 110 mm Hg)
11. Pregnant patients / lactating patients, female patients who wish to become pregnant during the study
12. Being or supposed to be under medication with mercaptopurine hydrate and azathioprine that are contraindicated with topiroxostat.
13. Any antihypertensive drugs have been changed within a month or will be changed after the trial registration
14. Currently participating in other intervention studies (no restrictions are applied to participation in other observational study)
15. Suffering acute illnesses that may affect the effectiveness and safety until the main registration after primary registration
16. The participation to this study is judged inappropriate by the attending physicianto
Target sample size 370

Research contact person
Name of lead principal investigator
1st name Yoshihiko
Middle name
Last name Saito
Organization Nara medical Univ
Division name Department of cardiovascular medicine
Zip code 634-8521
Address 840 Shijo-cho Kashihara Nara
TEL 0744-22-3051
Email yssaito@naramed-u.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Kasahara
Organization Nara Medical University Hospital
Division name Institute for Clinical and Translational Science
Zip code 634-8522
Address 840 Shijo-cho Kashihara Nara
TEL 0744-22-3051
Homepage URL
Email kasa@naramed-u.ac.jp

Sponsor
Institute Nara medical Univ
Institute
Department

Funding Source
Organization FUJIYAKUHIN
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 Nara Medical University Certified Review Board
Address 840 Shijo-cho Kashihara Nara
Tel 0744-29-8835
Email ethics_nara@naramed-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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 28 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030011

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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