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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010497
Receipt No. R000012146
Scientific Title Febuxostat Pharmacokinetics, Efficacy and Tolerability in Hemodialysis Patients with Hyperuricemia
Date of disclosure of the study information 2013/04/15
Last modified on 2013/04/15

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Basic information
Public title Febuxostat Pharmacokinetics, Efficacy and Tolerability in Hemodialysis Patients with Hyperuricemia
Acronym Febuxostat Pharmacokinetics, Efficacy and Tolerability in Hemodialysis Patients with Hyperuricemia
Scientific Title Febuxostat Pharmacokinetics, Efficacy and Tolerability in Hemodialysis Patients with Hyperuricemia
Scientific Title:Acronym Febuxostat Pharmacokinetics, Efficacy and Tolerability in Hemodialysis Patients with Hyperuricemia
Region
Japan

Condition
Condition Hemodialysis patients with hyperuricemia
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the pharmacokinetics, efficacy in lowering serum urate levels, and tolerability of febuxostat in hemodialysis patients
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes - Pharmacokinetics (0-24 h) of febuxostat
- Dialysis clearance of febuxostat
- Efficacy of febuxostat in reducing serum urate levels
- Tolerability (adverse events) of febuxostat
Key secondary outcomes

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 Drug name: Feburic Tablets (generic name: febuxostat)
Dose and dosing interval
Oral dose of 10 mg (one 10 mg tablet or one half of a 20 mg tablet) after breakfast (preferably within 30 min)
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. Age: 20 years or older
2. Sex: Male or female
3. Patients with urine output <= 100 mL
4. Patients on stable maintenance hemodialysis who are admitted to the hospital for routine medical examination
5. Hyperuricemic patients with serum urate level > 7.0 mg/dL
6. Patients not receiving antihyperuricemics for at least 2 weeks
7. Patients who signed the informed consent to participate in the study
Key exclusion criteria Patients who meet any of the following criteria will be excluded from the study:
1. Patients who present with gouty arthritis at the time of the examination before entry or at entry, or those in whom gouty arthritis had resolved only 2 weeks or sooner before entry
2. Patients who received drugs that must not be used within 2 weeks before entry
3. Patients complicated with any of the following diseases at entry:
(i) Lesch-Nyhan syndrome [deficiency of hypoxanthine-phosphoribosyltransferase (HPRT)], (ii) elevated 5-phosphoribosyl-1-pyrophosphatase (PRPPase), (iii) congenital myogenic hyperuricemia, (iv) psoriasis vulgaris, (v) hemolytic anemia, (vi) hypothyroidism, (vii) rhabdomyolysis, (viii) glycogenosis I (due to lactic acidemia), (ix) toxemia of pregnancy, (x) polycystic kidney disease, (xi) lead nephropathy, (xii) Down syndrome, (xiii) sarcoidosis
4. Patients with liver damage (ALT >= 100 IU/L)
5. Patients with a history of hypersensitivity to febuxostat preparations
6. Patients who are or may be pregnant or breast-feeding
7. Patients receiving mercaptopurine hydrate or azathioprine
8. Other patients judged by the investigator to be ineligible for entry into the study
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Syunya Uchida
Organization Teikyo University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Syunya Uchida
Organization Teikyo University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization None
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
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 帝京大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 04 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 07 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 31 Day
Last follow-up date
2013 Year 07 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
2013 Year 04 Month 15 Day
Last modified on
2013 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012146

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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