UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014309 |
|---|---|
| Receipt number | R000016660 |
| Scientific Title | A randomized trial Comparing the Effects of Febuxostat and Allopurinol on renal function and left ventricular hypertrophy for chronic heart failure patient with hyperuricemia complicated by chronic kidney disease stage G3-G4. |
| Date of disclosure of the study information | 2014/06/19 |
| Last modified on | 2019/12/22 14:28:19 |
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Basic information
Public title
A randomized trial Comparing the Effects of Febuxostat and Allopurinol on renal function and left ventricular hypertrophy for chronic heart failure patient with hyperuricemia complicated by chronic kidney disease stage G3-G4.
Acronym
CEFIRO study
Scientific Title
A randomized trial Comparing the Effects of Febuxostat and Allopurinol on renal function and left ventricular hypertrophy for chronic heart failure patient with hyperuricemia complicated by chronic kidney disease stage G3-G4.
Scientific Title:Acronym
CEFIRO study
Region
| Japan |
Condition
Condition
Chronic heart failure patients with hyperuricemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is comparing the effects of Febuxostat and AllopurInol on renal function for chronic heart failure patient with hyperuricemia complicated by chronic kidney disease stage G3-G4
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
eGFR slope (change of eGFR from the baseline to 52 weeks)
Key secondary outcomes
1) Cardiac function indexes on echocardiography (LVEF, LVMI, LVEDV, LVESV, %FS, RWT) and (E, A, DT, E/e')
2) The amount of change of serum uric acid value and BNP
3) The amount of change of urine protein,urinecreatinine, the albumin urine/creatinine ratio and the albumin urine
4) The amount of change of eGFR and cystatin C
5) The amount of change of L-FABP and o-LDL
6) The amount of change of hsCRP
7) The amount of change of EPA/AA
8) Achievement quotient of serum uric level urine 6.0mg/dl
9) Incidence of adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Febuxostat group: Patients take febuxostat by oral administration for 52 weeks (approximately one year).
Chronic heart failure patient with hyperuricemia (Uric acid more than 7mg/dl) are scheduled to treat with 10 mg/day of febuxostat in the beginnings. The doses of febxostat are allowed to increase until 40mg/day, if the serum levels of uric acid were not controlled to the target values (Uric acid less than 6mg/dl).
Interventions/Control_2
Allopurinol group: Patients take allopurinol by oral administration for 52 weeks (approximately one year).
Chronic heart failure patient with hyperuricemia (Uric acid more than 7mg/dl) are scheduled to treat with 50mg/day of allopurinol in the beginnings. The dose of allopurinol is allowed to increase until 300mg/day, when the eGFR of the patients were more than 50 ml/min/1.73m2. Similarly, the dose of allopurinol is allowed to increase until 100mg/day, when the eGFR of the patients were equal or less than 50 ml/min/1.73m2
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) Male or female outpatients over 20 years old at time the subjects sign the Informed Consent Form (ICF).
2) Serum uric acid level >7.0 mg/dL
3) Without taking drugs lowered uric acid within 3 month before the treatment start
4) CHF, NYHA functional class II - III and systolic dysfunction, LVEF<40%
5) Stable for heart failure, without changes in NYHA functional class
6) The eGFR of the patients are between 15 and 60 ml/min/1.73m2.
7) Written informed consent by his/her own will.
Key exclusion criteria
1) Patients who have allergy to febuxostat or allopurinol.
2) Patients who take mercaptopurine or azathioprine.
3) Nephrotic syndrome,dialysis patients,renal transplant or on other serious disease
4) Patients with AST or ALT level over than the twice the facilitie standard value.
5) Patients who have complication of malignant tumor.
6) Pregnant, possibly pregnant, brest-feeding, or expecting to conceive.
7) Written informed consent by his/her own will not.
8) Patients who are judged as inadequate to participate the study by the their doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hasebe |
Organization
Asahikawa Medical University
Division name
Cardiovascular Respiratory and Neurology Division, Department of Internal Medicine
Zip code
078-8510
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2442
haselove@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiharu |
| Middle name | |
| Last name | Takeuchi |
Organization
Asahikawa Medical University
Division name
Cardiovascular Respiratory and Neurology Division, Department of Internal Medicine
Zip code
078-8510
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2442
Homepage URL
take21@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2187
sho-kenkyu@jimu.asahikawa-med.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
| 2014 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016660
