UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012628 |
|---|---|
| Receipt number | R000014765 |
| Scientific Title | Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2013/12/19 14:30:15 |
* 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
Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy
Acronym
Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy
Scientific Title
Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy
Scientific Title:Acronym
Examination of the effect of a combination of benzbromarone and febuxostat in patients with hyperuricemia complicating diabetic nephropathy
Region
| Japan |
Condition
Condition
hyperuricemia
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this research, the combination therapy of febuxostat and benzbromarone, a uricosuric agent, will be administered to patients with hyperuricemia complicating diabetic nephropathy to examine the efficacy and safety of the combination therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of hyperuricemia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with hyperuricemia (serum uric acid level ≥ 8 mg/dL) complicating diabetic nephropathy [stage 3A (GFR < 60 mL/minute/1.73 m2, proteinuria < 1 g/day) or stage 3B (GFR < 60 mL/minute/1.73 m2, proteinuria ≥ 1 g/day)], who have failed to control the serum uric acid level at 6.0 mg/dL or lower even with 20 mg/day of febuxostat administered orally for at least 4 weeks and who have provided consent to participate in this research will be divided into 2 groups. The febuxostat dose will be increased to a maximum of 40 mg/day in the febuxostat dose-increase group and will be started at 25 mg/day and increased to a maximum of 50 mg/day in the benzbromarone combination group.
Interventions/Control_2
Patients with hyperuricemia (serum uric acid level ≥ 8 mg/dL) complicating diabetic nephropathy who have failed to control serum uric acid level at 6.0 mg/dL or lower even after taking febuxostat at 20 mg/day for at least 4 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hyperuricemia (serum uric acid level ≥ 8 mg/dL) complicating diabetic nephropathy who have failed to control serum uric acid level at 6.0 mg/dL or lower even after taking febuxostat at 20 mg/day for at least 4 weeks.
Key exclusion criteria
(1) Patients contraindicated for benzbromarone, including
1) patients with hepatic disorders [ALT (GPT) ≥ 100 IU/L],
2) patients with renal calculus and/or with severe renal function impairment (diabetic nephropathy stage 4 or more severe),
3) pregnant or possibly pregnant women, and
4) patients with a history of hypersensitivity to any ingredient of the product;
(2) Patients contraindicated for febuxostat, including
1) patients with a history of hypersensitivity to any ingredient of the product and
2) patients on treatment with mercaptopurine hydrate or azathioprine; and
(3) Other patients judged inappropriate by the physician in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsumi Iizuka |
Organization
Gifu university hospital
Division name
Department of diabetes and metabolism
Zip code
Address
1-1 yanagido, Gifu
TEL
+81-58-230-6377
kiizuka@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsumi Iizuka |
Organization
Gifu university hospital
Division name
Department of diabetes and meatbolism
Zip code
Address
1-1 yanagido, Gifu
TEL
+81-58-230-6377
Homepage URL
kiizuka@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University hospital
Institute
Department
Personal name
Funding Source
Organization
Torii Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 12 | Month | 19 | 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
| 2013 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014765
