UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015547 |
|---|---|
| Receipt number | R000017947 |
| Scientific Title | Study of the effects of febuxostat in patients with diabetic nephropathy. |
| Date of disclosure of the study information | 2014/10/28 |
| Last modified on | 2015/03/30 12:01:57 |
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Basic information
Public title
Study of the effects of febuxostat in patients with diabetic nephropathy.
Acronym
Study of the effects of febuxostat in patients with diabetic nephropathy.
Scientific Title
Study of the effects of febuxostat in patients with diabetic nephropathy.
Scientific Title:Acronym
Study of the effects of febuxostat in patients with diabetic nephropathy.
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of febuxostat administration for diabetic nephropathy patients with hyperuricemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of podocyte in Urinary(pieces/mL)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Febuxostat 10-60mg, once daily, oral
Interventions/Control_2
Febuxostat will not be used
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Type 2 Diabetes Mellitus
2)Renal function is Moderate
3)Serum uric acid level is 7.0 - 10.0mg/dL in the past six months, patients with no history of gout attack
4)Age 20 years old or older
5)Informed consent was obtained from the patients
Key exclusion criteria
1)Patients with a history of hypersensitivity to febuxostat
2)Patients with secondary hyperuricemia
3)Systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or more
4)AST or ALT levels are more than double of the normal range
5)Patients who have the following disease were excluded.
Non- diabetic chronic kidney disease: glomerulonephritis , renal sclerosis , polycystic kidney disease , inflammatory disease or infection, malignant tumor
6)Patients who develop coronary artery disease , cerebrovascular disease within six months
7)Patients who are administered mercaptopurine hydrate (Roikerin), azathioprine (Imran Azanin)
8)Alcoholics(2 Go / day or more sake in a week average)
9)Patients in Breast-feeding or pregnancy
10)Patients judged by the investigator to be ineligible for some other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Toyoda |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0563-93-1121
m-toyoda@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakana Miura |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0563-93-1121
Homepage URL
happy0897@gmail.com
Sponsor or person
Institute
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 10 | 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
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 28 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017947
