UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000010
Receipt number R000000015
Scientific Title Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children
Date of disclosure of the study information 2005/08/01
Last modified on 2010/11/12 10:06:40

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Basic information

Public title

Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children

Acronym

Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children

Scientific Title

Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children

Scientific Title:Acronym

Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children

Region

Japan


Condition

Condition

Frequently relapsing nephrotic syndrome in children

Classification by specialty

Nephrology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate efficacy and safety of cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relapse-free rate

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

Cyclosporine C0 monitoring

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

18 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.Frequently relapses or prednisolone dependence, based on the International study of kidney disease in children.
3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed before eligibility.
4.Aged twelve months to 18 years.
5.Written informed consent from the patients' parents or legal guardians.

Key exclusion criteria

1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus).
2.History of steroid-resistance.
3.Medical history of allergy or hypersensitivity reactions to cyclosporine.
4.Poorly controlled hypertension.
5.Chronic renal dysfunction.
6.Active infectious disease.
7.Severe liver disfunction.
8.History of cyclosporine administration.
9.Pregnancy.
10.Judged inappropriate for this study by the physicians.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Ikeda

Organization

Tokyo Metropolitan Children's Hospital

Division name

Department of Nephrology

Zip code


Address

1-3-1Umezono Kiyose City,Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Japanese Study Group of Renal Disease in Children

Division name

Department of Nephrology,Tokyo Metropolitan Children's Hospital

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Japanese Study Group of Renal Disease in Children

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

2005 Year 08 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

Completed

Date of protocol fixation

2000 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2000 Year 01 Month 01 Day

Last follow-up date

2007 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 06 Month 14 Day

Last modified on

2010 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000015


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name