TARGET-UA

JRCT ID: jRCTs051180146

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with CKD and hyperuricemia
• Date of first enrollment: 24/11/2017
• Target sample size: 370
• Study type: Interventional

Intervention(s)

1: Intensive therapy group with Topiroxostat
Target serum uric acid level: 4.0 mg/dL to 5.0 mg/dL
Maximum usage of Topiroxostat is 160 mg per day.
2: Standard therapy group with Topiroxostat
Target serum uric acid level: 6.0 mg/dL to 7.0 mg/dL
Maximum usage of Topiroxostat is 160 mg per day.

Outcome(s)

• Primary Outcome: Changes in urinary albumin-to-creatinine ratio

Secondary Outcome

1) Change in serum UA
2) Extent change in eGFR
3) Category change of urine protein
4) Composite cardiovascular events (Newly diagnosed myocardial infarction, Angina requiring revascularization, Heart failure requiring hospitalization, Stroke [cerebral infarction / cerebral hemorrhage], Peripheral arterial disease requiring revascularization, Carotid artery stenosis requiring stent implantation or endarterectomy, Carotid artery stenosis requiring stent implantation or endarterectomy, Aortic aneurysm or dissection requiring hospitalization, Sudden death
5) Renal event(Appearance of overt proteinuria, Increase of serum Creatinine to 2.0 mg/dL or more, and 2 times or more, Initiation of renal replacement therapy [initiation of dialysis or renal transplantation])
6) Presence or frequency for onset of gout arthritis or urinary stone attack
7) Change in lipid profile

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patinets aged 20 years and older
2.Stage 3 CKD patients (30<=eGFR<60ml/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

Exclude 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 physician

Related Information

• Primary Sponsor: Saito Yoshihiko
• Source(s) of Monetary Support: Fuji Yakuhin Co., Ltd.
• Secondary ID(s): UMIN000026741