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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009942
Receipt No. R000011646
Scientific Title Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial
Date of disclosure of the study information 2013/02/15
Last modified on 2013/07/04

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Basic information
Public title Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial
Acronym Reno-protective Effect of Febuxostat in Renal-dysfunctional Secondary Hyperuricemia (Tohoku REFRESH study)
Scientific Title Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial
Scientific Title:Acronym Reno-protective Effect of Febuxostat in Renal-dysfunctional Secondary Hyperuricemia (Tohoku REFRESH study)
Region
Japan

Condition
Condition Hyperuricemia, chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate anti-proteinuric effect of febuxostat in CKD patients with hyperuricemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Urinary protein creatinine ratio at 24 weeks after treatments
Key secondary outcomes Chronological changes of urinary protein excretion from the baseline to 24 weeks and those from 24 to 48 weeks. Estimated GFR, plasma renin activity, plasma aldosterone concentration, urinary albumin creatinine ratio, urinary L-FABP, urinary 8-OHdG, serum methylglyoxal, and blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Febuxostat 10-60 mg/day to target serum urate range from 4 to 6 mg/dL from the baseline to 48 weeks
Interventions/Control_2 Conventional treatments (allopurinol and/or benzbromarone, or no drug) to target serum urate range from 8 to 10 mg/dL from the baseline to 24 weeks, and febuxostat 10-60 mg/day to target serum urate range from 4 to 6 mg/dL from 24 to 48 weeks
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) Obtained written informed consent from the patient for the study participation 2) Stable condition for more than 3 months on the treatments by a nephrologist 3) Age >-20 and <80 years old 4) eGFR >-15 and <45 mL/min/1.73m2 5) Serum uric acid >-7.0 mg/dL and <11.0 mg/dL 6) Urinary protein creatinine ratio >-0.3 and <3.5 g/gCr 7) Outpatient who can visit bimonthly at least
Key exclusion criteria 1) High-risk patients requiring dialysis or renal transplantation within 48 weeks 2) History of gout 3) Patients with Cancer or liver disease (HBV/HCV hepatitis, cirrhosis, and the other liver injuries showing AST/ALT values more than twice as high of normal values 4) HbA1c (JDS) >-7.0% with 2 months prior to the entry 5) Office systolic blood pressure >-160 mmHg or diastolic blood pressure >-100 mmHg both at recent twice office visits before the entry 6) Severe heart failure or edema 7) History of renal replacement therapy 8) History of febuxostat intake within four weeks before the entry 9) History of hypersensitivity to allopurinol, benzbromarone, or febuxostat 10) Judged as ineligible in the opinion of the attending physician 11) Pregnancy or nursing
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mariko Miyazaki
Organization Tohoku University Graduate School of Medicine
Division name Division of Nephrology, Endocrinology, and Vascular Medicine
Zip code
Address 2-1 Seiryo-Cho, Aoba-Ku, Sendai 980-8574
TEL 022-717-7163
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakamichi
Organization Tohoku University Graduate School of Medicine
Division name Division of Nephrology, Endocrinology, and Vascular Medicine
Zip code
Address 2-1 Seiryo-Cho, Aoba-Ku, Sendai 980-8574
TEL 022-717-7163
Homepage URL
Email tnakamichi@med.tohokou.ac.jp

Sponsor
Institute Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Teijin pharma limited
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
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 東北大学病院(宮城県) Tohoku University Hospital, Miyagi prefecture
岩手県立中央病院(岩手県) Iwate Prefectural Central Hospital, Iwate prefecture

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 15 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 Enrolling by invitation
Date of protocol fixation
2012 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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
2013 Year 02 Month 03 Day
Last modified on
2013 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011646

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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