UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017470
Receipt number R000020246
Scientific Title Study on the effect of rituximab for steroid-dependent nephrotic syndrome
Date of disclosure of the study information 2015/05/08
Last modified on 2015/05/08 18:45:25

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Basic information

Public title

Study on the effect of rituximab for steroid-dependent nephrotic syndrome

Acronym

R-SDNS Study

Scientific Title

Study on the effect of rituximab for steroid-dependent nephrotic syndrome

Scientific Title:Acronym

R-SDNS Study

Region

Japan


Condition

Condition

steroid-dependent nephrotic syndrome

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine of the effect and safety of rituximab for steroid-dependent nephrotic syndrome

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Duration of remission

Key secondary outcomes



Base

Study type


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

Administration of rituximab

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patietns with primary nephrotic syndrome
2. Patients who had a history of frequent relapse
3. Patients who provided written informed consent for participating this study.

Key exclusion criteria

1. Patients who had a history of severe anaphylactic reaction
2. Patients with severe heart disease, hepatic dysfunction and respiratory dysfunction
3. Patients with hepatitis B virus carrier or infection
4. Patients who are pregnant or lactating
5. Patients who are not eligible for this study at the discretion of the investigator

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanari Kitazono

Organization

Graduate School Medical Sciences, Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5250

Email

kitazono@intmed2.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Tsuruya

Organization

Graduate School Medical Sciences, Kyushu University

Division name

Department of Integrated Therapy for Chronic Kidney Disease

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5843

Homepage URL


Email

tsuruya@intmed2.med.kyushu-u.ac.jp


Sponsor or person

Institute

Graduate School Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Graduate School Medical Sciences, Kyushu University

Organization

Division

Category of Funding Organization

Other

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

2015 Year 05 Month 08 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

Enrolling by invitation

Date of protocol fixation

2013 Year 11 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 12 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

2015 Year 05 Month 08 Day

Last modified on

2015 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name