UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026741 |
|---|---|
| Receipt number | 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 | 2022/04/05 18:10:18 |
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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
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
kasa@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical Univ
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030011
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
