UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015403 |
|---|---|
| Receipt number | 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 14:36:08 |
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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
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
marus@med.nagoya-u.ac.jp
Public contact
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
Kato07@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Nephrology,
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017504
