UMIN-CTR Clinical Trial

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

Hemodialysis patients with hyperuricemia

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Teikyo University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

帝京大学医学部付属病院（東京都）

Date of disclosure of the study information

2013

Year

04

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

04

Month

15

Day

Last modified on

2013

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012146