UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 03 Month 13 Day
Date of IRB	2017 Year 04 Month 17 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry	2021 Year 09 Month 24 Day
Date trial data considered complete	2021 Year 10 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030011