UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008909 |
|---|---|
| Receipt number | R000010296 |
| Scientific Title | Effects of febuxostat on serum uric acid and arteriosclerosis in allopurinol-treated hyperuricemia patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/03/16 21:51:27 |
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Basic information
Public title
Effects of febuxostat on serum uric acid and arteriosclerosis in allopurinol-treated hyperuricemia patients with chronic kidney disease
Acronym
Effects of febuxostat on arteriosclerosis in hyperuricemia patients with CKD
Scientific Title
Effects of febuxostat on serum uric acid and arteriosclerosis in allopurinol-treated hyperuricemia patients with chronic kidney disease
Scientific Title:Acronym
Effects of febuxostat on arteriosclerosis in hyperuricemia patients with CKD
Region
| Japan |
Condition
Condition
Hyperuricemia patients with chronic kidney disease G3a, G3b
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of febuxostat on serum uric acid and arteriosclerosis in allopurinol-treated hyperuricemia patients with chronic kidney disease G3a, G3b
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of the below parameters
1) Serum uric acid level
2) Indexes of arteriosclerosis (cardio-ankle vascular index, carotid intima-media thickness)
Key secondary outcomes
1) Changes of the below parameters
Systolic/diastolic blood pressure, estimated glomerular filtration rate, cystatin C, C-reactive protein, urinary protein/albumin excretion
2) Achievement ratio of less than 7.0mg/dl in serum uric acid level
(Achievement ratio of less than 6.0mg/dl in patients with the past history of gout or hypertension)
3) Incidence of gout/urolithiasis
4) Incidence of cardio-vascular diseases
5) Incidence of dialysis therapy
6) Incidence of detrimental events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Change of hyperuricemia drugs from allopurinol to febuxostat and administration of febuxostat for a period of 48 weeks
Interventions/Control_2
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
1) Estimated glomerular filtration rate (ml/min/1.73m2) is more than 30 and less than 60.
2) Serum uric acid level has not lowered at less than 7.0mg/dl in two consecutive tests before checking the eligibility, when the patient has been treated by less than 100mg/day allopurinol.
3) Serum uric acid level has not lowered at less than 6.0mg/dl on the above condition in patients with the past history of gout or hypertension).
4) Patients with the informed consent to this study
Key exclusion criteria
1) Patients treated by febuxostat currently or within 24 weeks before checking the eligibility
2) Patients with past hypersensitivity to febuxostat
3) Past histories of gout or urolithiasis within 24 weeks before checking the eligibility
4) Patients with diabetes controlled insufficiently (HbA1c level is more than 8.4%)
5) Patients whose systolic or diastolic blood pressure show more than 160mmHg or more than 100mmHg, respectively
6) Patients whose AST or ALT show twice more than the upper limit of reference values
7) Past hospitalization within 24 weeks before checking the eligibility
8) Patients with current or past malignant tumor
However, patients who have not been treated for malignant tumor within 5 years before checking the eligibility and show no recurrence when checking the eligibility are not excluded.
9) Patients with severe cardiovascular diseases
10) Patients currently treated for inflammatory or consumptive diseases
11) Patients currently treated for acute renal failure, active nephritis or nephrotic syndrome
12) Patients treated by steroids or immunosuppressive agents
13) Patients treated by one of the below drugs when checking the eligibility
Mercaptopurine hydrate, azathioprine, vidarabine, didanosine
14) Patients with administration, dose change or discontinuance of one of the below drugs within 4 weeks before checking the eligibility
Losartan, fenofibrate, thiazide or loop diuretic
15) Patients currently treated by salicylate drugs
However, patients treated by low-dose aspirin (less than 324mg/day) are not excluded.
16) Patients with hormone replacement therapy by estrogen
17) Patients who have participated in the other clinical study (trial) within 24 weeks before checking the eligibility
18) Female in current or expected pregnancy
19) Patients judged as unsuitable for participating in this study by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Komai |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
komai@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamehachi Namikoshi |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Homepage URL
tnamikoshi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 16 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 12 | Day |
Last modified on
| 2015 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010296
