UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of febuxostat in patients with chronic kidney disease
Title of the study (Brief title)	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	Tsuyoshi Watanabe
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endcrinology, and Metabolism
Address	Hikarigaoka 1, Fukushima City
TEL	024-547-1206
Email	im3@fmu.ac.jp

Public contact
Name of contact person	Kenichi Tanaka
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endcrinology, and Metabolism
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008825