UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007088
Receipt number R000008347
Scientific Title The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
Date of disclosure of the study information 2012/01/17
Last modified on 2014/07/17 09:17:30

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Basic information

Public title

The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment

Acronym

The NovEl XOI, FebuxostaT; Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
(NEXT-STAR)

Scientific Title

The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment

Scientific Title:Acronym

The NovEl XOI, FebuxostaT; Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment
(NEXT-STAR)

Region

Japan


Condition

Condition

Hyperuricemia with moderate to severe renal impairment

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety, torelability, and effect on serum uric acid and renal function of Febuxostat in hyperuricemia patients associated with moderate to severe renal impairment

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety and Torelability:
Adverse event, number and incidence
Laboratory test
Vital sign, Blood Pressure

Key secondary outcomes

Serum uric acid value
Change rate of serum uric acid
Achievement rate of serum uric acid at 6.0mg/dL or less
Change rate of eGFR
Protein amount in urine


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

Febuxostat is administered in dose escalation manner as follows, with careful check of safety and tolerability at each dose:
- Start 10 mg, once daily
- At 4 weeks after starting, dose up to 20 mg, once daily,
At 8 weeks after starting, dose up to 40 mg, once daily
Maximum dose is 60 mg once daily. If necessary, dose should be reduced to 40 mg after dosing up to 60 mg once daily.

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

Gout or hyperuricemia patients eligible for all the points of the following:
(1) Japanese male or female, 20 years old or above at the time of informed consent
(2) Serum uric acid > 8.0mg/dL
(3) eGFR< 45 mL/min./1.73 m2 Moderate (CKD stage 3b) to severe (CKD stage 4-5) renal impairment
(4) Not treated with uric acid lowering agent within 1 month before the timing of eligibility judgement
(5) Patinets from which informed consent is obtained
*: eGFR is calculated based on Japanese GFR formula
eGFR (mL/min/1.73 m2) = 194 x Serum creatinine(-1.094) x Age(-0.287) x 0.739 (if female)

Key exclusion criteria

(1)Patients having gouty attach at the time of eligibility judgment, or within 2 weeks after being cured from gout attack.
(2)Hepatic impairment patients (AST, ALT is more than double of standard values)
(3)Patients with unstable renal impairment, (50 % of change in sCR within 3 months), acute renal diseases or dialysis
(4)Patients having plan to receive dialysis or renal transplantaion during study
(5)Patinets having malignancy or other severe diseases
(6)Patients with hypersensitivity to febuxostat
(7)Pregnant female, lactation femal, hoping gestation
(8)Treated patients with mercaptopurine or azathioprine
(9)Patients whom study physicians consider as not eligible.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iwao Ohno1),Yugo Shibagaki2)

Organization

1) Jikei University School of Medicine,
2) St Marianna University

Division name

1)Division of Kidney and Hypertension, 2)Division of Nephrology and Hypertension

Zip code


Address

1)3-25-8 Nishi-Shinbashi Minato-ku Tokyo, 2)2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa

TEL

03-3433-1111

Email

i-ohno@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Iwao Ohno1),Yugo Shibagaki2)

Organization

1) Jikei University School of Medicine, 2) St Marianna University

Division name

1)Division of Kidney and Hypertension, 2)Division of Nephrology and Hypertension

Zip code


Address

1)3-25-8 Nishi-Shinbashi Minato-ku Tokyo,2) 2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa

TEL

03-3433-1111

Homepage URL


Email

i-ohno@jikei.ac.jp


Sponsor or person

Institute

1) Jikei University School of Medicine, 2) St Marianna University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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



Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 01 Month 17 Day

Last modified on

2014 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008347


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name