UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000158
Receipt number R000000016
Scientific Title Mizoribin for primary nephrotic syndrome in children(JSRDC09)
Date of disclosure of the study information 2006/04/01
Last modified on 2008/12/09 09:52:11

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Basic information

Public title

Mizoribin for primary nephrotic syndrome in children(JSRDC09)

Acronym

Mizoribin for primary nephrotic syndrome in children(JSRDC09)

Scientific Title

Mizoribin for primary nephrotic syndrome in children(JSRDC09)

Scientific Title:Acronym

Mizoribin for primary nephrotic syndrome in children(JSRDC09)

Region

Japan


Condition

Condition

Steroid-sensitive nephrotic syndrome

Classification by specialty

Nephrology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate efficacy and safety of a combination of mizoribine and prednisolone for steroid-sensitive nephrotic syndrome in children, comparing with prednisolone.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relapse-free proportion

Key secondary outcomes

Relapse-free time
Freaquently relapse rate
Steroid dependency rate
Relapse rate
Proportion f adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

mizoribine+prednisolone

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

1 years-old <=

Age-upper limit

10 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL).
2.Patients with treatment either based on the International study of kidney disease in children (ISKDC) or similar to ISKDC.
3.Steroid-sensitive nephrotic syndrome in first onset.
4.Biopsy diagnoses of MCNS, where a renal biopsy has been performed before eligibility, in the patients with hematuria.
5.Aged twelve months to 18 years.
6.Written informed consent from the patients' parents or legal guardians.

Key exclusion criteria

1.History of relapse.
2.Medical history of allergy or hypersensitivity reactions to mizoribine.
3.Poorly controlled hypertension.
4.Chronic renal dysfunction.
5.Active infectious disease.
6.Severe liver disfunction.
7.Hypocomplementemia
8.Pregnancy.
9.Judged inappropriate for this study by the physicians.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norishige Yosikawa

Organization

Wakayama Medical University

Division name

Department of Pediatrics

Zip code


Address

811-1 Kimiidera Wakayama City Wakayama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Japanese Study Group of Renal Disease in Children(JSRDC)

Division name

Department of Pediatrics,Wakayama Medical University

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Japanese Study Group of Renal Disease in Children(JSRDC)

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation,Japan

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2006 Year 04 Month 01 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

Terminated

Date of protocol fixation

2006 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2006 Year 03 Month 01 Day

Last follow-up date

2010 Year 08 Month 01 Day

Date of closure to data entry

2010 Year 08 Month 01 Day

Date trial data considered complete

2010 Year 08 Month 01 Day

Date analysis concluded

2010 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 11 Day

Last modified on

2008 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000016


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name