UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008942 |
|---|---|
| Receipt number | R000010412 |
| Scientific Title | A Randomized Trial Assessing the Effect of Intensive Control of Hyperuricemia on Kidney Function in CKD Patients |
| Date of disclosure of the study information | 2012/09/19 |
| Last modified on | 2021/03/22 08:54:48 |
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Basic information
Public title
A Randomized Trial Assessing the Effect of Intensive Control of Hyperuricemia on Kidney Function in CKD Patients
Acronym
Hyperuricemia and CKD trial (URIC TRIAL)
Scientific Title
A Randomized Trial Assessing the Effect of Intensive Control of Hyperuricemia on Kidney Function in CKD Patients
Scientific Title:Acronym
Hyperuricemia and CKD trial (URIC TRIAL)
Region
| Japan |
Condition
Condition
Patients with CKD stage G4 (KDIGO 2012) and hyperuricemia (7.0mg/dl<=)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the intensive control of hyperuricemia slows the rate of decline in eGFR in patients with CKD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the changes in eGFR levels between before and after the drug intervention
Key secondary outcomes
the changes in parameters listed below between before and after the drug intervention
1) serum UA levels
2) serum high-sensitive CRP levels
3) levels of albuminuria
4) urinary 8-OHdG levels
5) urinary L-FABP levels
End-stage kidney diseases requiring renal replacement therapy
Cardiovascular events
Any serious adverse events considered to be related to the drug intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intensive treatment group: patients are administered febuxostat to reduce serum UA levels below 6 mg/dL during 24 months observation period. Initial dose is 20 mg/dL. The dose of febuxostat can be increased by 20 mg/day every 4 weeks up to 60mg/day to achieve the target UA levels.
Interventions/Control_2
Control group: patients' UA levels are controlled in between 7 and 10 mg/dL with conventional drugs during 24 months observation period.
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)15mL/min/1.73m2 <= eGFR < 30 mL/min/1.73m2
(2)the serum UA levels are higher than 7.0 mg/dL
Key exclusion criteria
(1)Patients who have active inflammatory diseases, active cerebro-cardiovascular diseases, and gastrointestinal diseases.
(2)severe hypertension defined as systolic blood pressure higher than 180mmHg or diastolic blood pressure higher than 110mmHg
(3)Uncontrolled diabetes: HbA1c > 8% (NGSP)
(4)Hyperkalemia: K > 6.0 mEq/L
(5)history of AKI over stage 2 within recent 3 months.
(6)Past history of renal transplantation
(7)Liver dysfunction: ASL or ALT levels more than three times as normal limit.
(8)Patients who are under treatment with mercaptopurine or azathioprine.
(9)Patients who have allergy for the drugs used in this trial.
(10)Patients who are pregnant, or how have possibility or willing of pregnancy.
(11)Patients who are breast-feeding.
(12)Patients with malignancy
(13)post-renal kidney diseases
(14)Patients who have gout attacks within recent one month
(15)Patients who are judged by the participating doctors as inappropriate participants.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Mukoyama |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Nephrology
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-City, Kumamoto 860-8556, Japan
TEL
096-373-5164
mmuko@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Kajiwara |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Division of Nephrology
Zip code
8600008
Address
1-5 Ninomaru, Chuo-ku, Kumamoto-City, Kumamoto 860-0008, Japan
TEL
096-353-6501
Homepage URL
kengoffice@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Graduate School of Medical Sciences
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-City, Kumamoto 860-8556, Japan
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.ac.jp
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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010412
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
