UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004653
Receipt number R000003261
Scientific Title The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS
Date of disclosure of the study information 2010/12/02
Last modified on 2010/12/02 13:40:03

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Basic information

Public title

The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS

Acronym

The effects of cyclosporine in onset MCNS

Scientific Title

The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS

Scientific Title:Acronym

The effects of cyclosporine in onset MCNS

Region

Japan


Condition

Condition

minimal change nephrotic syndrome

Classification by specialty

Medicine in general Nephrology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

From the viewpoint of medical administration, improvement in QOL and shortening of hospitalization are demanded in treatment of nephritic syndrome patients.
Therefore, we examined a trial in primary care of onset MCNS to evaluate the clinical effect, safety and hospitalization shortening of CsA combination therapy with MPT.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

shortening of hospitalization, reduction in adverse effects, prevention of relapse, reduction in dose of corticosteroid

Key secondary outcomes

reduction in days required for complete remission, blood and urine chemistry data of 6 and 12 months after discharge


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cyclosporine A 2-3mg/kg/day

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

minimal change nephrotic syndrome patients that do not have underlying disease

Key exclusion criteria

minimal change nephrotic syndrome patients that have underlying disease

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuhito hirawa

Organization

Yokohama city university medical center

Division name

division of Nephrology and Hypertension

Zip code


Address

4-57 urafunecho minamiku yokohama-shi kanagawa-ken Japan

TEL

045-261-5656

Email



Public contact

Name of contact person

1st name
Middle name
Last name Nobuhito hirawa

Organization

Yokohama city university medical center

Division name

division of Nephrology and Hypertension

Zip code


Address

4-57 urafunecho minamiku yokohama-shi kanagawa-ken Japan

TEL

045-261-5656

Homepage URL


Email



Sponsor or person

Institute

Yokohama city university graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama city university graduate school of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 02 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

No longer recruiting

Date of protocol fixation

2005 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 03 Month 01 Day

Date trial data considered complete

2013 Year 03 Month 01 Day

Date analysis concluded

2014 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 02 Day

Last modified on

2010 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name