UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007481
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email im3@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.