UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007481 |
|---|---|
| Receipt number | R000008825 |
| Scientific Title | Effect of febuxostat in patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2018/09/06 10:17:50 |
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Basic information
Public title
Effect of febuxostat in patients with chronic kidney disease
Acronym
Effect of febuxostat in patients with chronic kidney disease
Scientific Title
Effect of febuxostat in patients with chronic kidney disease
Scientific Title:Acronym
Effect of febuxostat in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease, hyperuricemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare reno-protective effect of febuxostat in chronic kidney disease patients with hyperuricemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Urinary tubular markers
2. Urinary albumin excretion
3. Serum systatin C, eGFR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Febuxostat group:
Patients in this group are initially given 10mg of febuxostat once daily for 12 weeks. Dosage of febuxostat are allowed to increase up to 40mg daily for the target value (serum uric acid below 6.0mg/dl).
Interventions/Control_2
2. Conventional therapy group:
The conventional therapies except medication of febuxostat are continued in these patients.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Chronic kidney disease stage 3.
2. Serum uric acid equal and more than 7mg/dl.
Key exclusion criteria
1. Patients with acute/chronic inflammatory disease and/or malignancy.
2. Patients with severe cardiovascular/respiratory/digestive disease within past 6 months.
3. Woman who is pregnant.
4. Patients who medicated with febuxostat and/or benzbromarone within past 3 months.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Watanabe |
Organization
Fukushima Medical University
Division name
Department of Nephrology, Hypertension, Diabetology, Endcrinology, and Metabolism
Zip code
Address
Hikarigaoka 1, Fukushima City
TEL
024-547-1206
im3@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Tanaka |
Organization
Fukushima Medical University
Division name
Department of Nephrology, Hypertension, Diabetology, Endcrinology, and Metabolism
Zip code
Address
Hikarigaoka 1, Fukushima City
TEL
024-547-1206
Homepage URL
im3@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 03 | Month | 09 | Day |
Last modified on
| 2018 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008825
