UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000015403
Receipt No. R000017504
Scientific Title Effect of Topiroxostat on Urinary Albumin in hyperuricemic patients with Diabetic nephropathy
Date of disclosure of the study information 2014/10/10
Last modified on 2019/04/01 (Ver. 9)

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Basic information
Public title Effect of Topiroxostat on Urinary Albumin in hyperuricemic patients with Diabetic nephropathy
Acronym ETUDE study
Scientific Title Effect of Topiroxostat on Urinary Albumin in hyperuricemic patients with Diabetic nephropathy
Scientific Title:Acronym ETUDE study
Region
Japan

Condition
Condition Diabetic nephropathy with hyperuricemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether Topiroxostat can reduce urinary albumin in patients with diabetic nephropathy and hyperuricemia.
Basic objectives2 Others
Basic objectives -Others To investigate whether Topiroxostat can improve in blood pressure, HbA1c, eGFR, serum uric acid level and urinary L-FABP level.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Amount of change in urinary albumin level at 24 weeks after administration using the urinary albumin level before administration at the benchmark
Key secondary outcomes -Change in urinary protein creatinine ratio
-Change in blood pressure (SBP, DBP) at outpatients clinic
-Change in HbA1c (NGSP)
-Change in eGFR
-Change in serum uric acid
-Change in urinary L-FABP
-Safety evaluation: adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 High dose of Topiroxostat
Interventions/Control_2 Low dose of Topiroxostat
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 Diabetes mellitus
2 Hyperuricemia
3 0.3 <= UPCR < 3.5g/gCr and eGFR >= 20 mL/min/1.73m2
4 Patients with under diet threrapy and exercise therapy 8 weeeks before enrollment
5 <= 20 years old
6 Patients who are able to write informed consent
7 Outpatient
Key exclusion criteria 1 Poor diabetic control
2 Patient have been treated with steroids
3 Patient with nephropathy excluding diabetic nephropathy (including: nephrosclerosis)
4 Cancer
5 Systemic disease with proteinuria (collagen disease, vasculitis and amyloidosis)
6 Gouty arthritis within 6 months
7 ALT, AST >= double as the standard of each hospital
8 Active Hepatitis C and/or C
9 Liver cirrhosis
10 Patients are deemed unsuitable by a physician
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name Shoichi
Middle name
Last name Maruyama
Organization Nagoya University Graduate School of Medicine
Division name Nephrology
Zip code 4658550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL +81-52-744-2192
Email marus@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name Sawako
Middle name
Last name Kato
Organization Nagoya University Graduate School of Medicine
Division name Nephrology
Zip code 4658550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2192
Homepage URL
Email Kato07@med.nagoya-u.ac.jp

Sponsor
Institute Department of Nephrology,
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Sanwa Kagaku Kenkyusho
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel 052-741-2111
Email ethics@med.nagoya-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 名古屋大学医学部附属病院、中部ろうさい病院、大垣市民病院、春日井市民病院、市立四日市病院、安城厚生病院、江南厚生病院、小牧市民病院、県立多治見病院、名古屋第二赤十字病院、津島市民病院、海南病院、中京病院

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 10 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/27303100
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28990729
Number of participants that the trial has enrolled 80
Results 
 The changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) relative to the baseline were -122 mg/gCr (95% CI: -5.1 to -240.1, P = 0.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P = 0.067).
Results date posted
2019 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 10 Month 09 Day
Baseline Characteristics 
The clinical characteristics and baseline laboratory data were similar in the two groups. The males (77.5%) were over represented as a result of enrolling in a sequence.
Participant flow 
Eighty Japanese patients were randomized in the trial from December 2014 to May 2016;the ETUDE study is a 24？week, multicentre, open label, randomized, parallel group study comparing the effects of topiroxostat 160？mg daily with topiroxostat 40？mg daily, both added to standard care.
Adverse events 
The adverse-event profile during this study was not different between the groups.
Outcome measures 
The primary endpoint was the change in albuminuria indicated by the UACR after 24？weeks (or the final time point if patients failed to reach 24？weeks) of treatment relative to the baseline values. The secondary endpoints were changes in UACR, eGFR, blood pressure (BP), serum UA, glycosylated haemoglobin (HbA1c), and L-type fatty acid binding protein at each time point.
And, urinary MCP-1, 8OHdG, Angiotensinogen
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 27 Day
Date of IRB
2014 Year 09 Month 12 Day
Anticipated trial start date
2014 Year 10 Month 10 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 10 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017504