UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000621
Receipt number R000000753
Scientific Title Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission
Date of disclosure of the study information 2007/02/28
Last modified on 2016/02/28 09:38:19

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Basic information

Public title

Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission

Acronym

ONTRACK

Scientific Title

Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission

Scientific Title:Acronym

ONTRACK

Region

Japan


Condition

Condition

Minimal change nephrotic syndrome

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this randomized, prospective, multicenter study is to reduce the number of relapses in nephrotic syndrome by increasing the initial immunosuppression and angiotensin II blockade

Basic objectives2

Others

Basic objectives -Others

Interventional study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The number of relapse after initial treatment and the duration of remission before the relapse

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Prednisolone (+), combination therapy (-)

Interventions/Control_2

Prednisolone (+), combination therapy (+)

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

Patients with minimal change nephrotic syndrome with first manifestation or relapse

Key exclusion criteria

1) Renal dysfunction (Ccr under 30 ml/min)
2) Histry of taking immunosuppressant within one month
3) Patients with malignant disease
4) Malabsorption syndrome or epilepsy
5) Severe heart, liver, or pancreatic disaese
6) Active infectious disease
7) Pregnancy
8) Hypersensitivity to cyclosporin
9) Hypersensitivity to ARB
10) Patients with FSGS
11) Others

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirofumi Makino

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

Division name

Department of Medicine and Clinical Science

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558, Japan

TEL

086-235-7235

Email

hitoshis@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Sugiyama

Organization

Okayama University Graduate School, Okayama, Japan

Division name

Department of Medicine and Clinical Science

Zip code


Address

2-5-1 Shikatacho Kitaku, Okayama, Japan

TEL

086-235-7235

Homepage URL


Email

sannai@cc.okayama-u.ac.jp


Sponsor or person

Institute

Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

Institute

Department

Personal name



Funding Source

Organization

Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

Organization

Division

Category of Funding Organization

Self funding

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

2007 Year 02 Month 28 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

2006 Year 11 Month 21 Day

Date of IRB


Anticipated trial start date

2007 Year 03 Month 01 Day

Last follow-up date

2011 Year 03 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

2007 Year 02 Month 28 Day

Last modified on

2016 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name