UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022150
Receipt number R000025524
Scientific Title The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.
Date of disclosure of the study information 2016/05/01
Last modified on 2020/05/05 13:29:40

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Basic information

Public title

The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.

Acronym

The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome.

Scientific Title

The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.

Scientific Title:Acronym

The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome.

Region

Japan


Condition

Condition

primary nephrotic syndrome

Classification by specialty

Nephrology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the efficacy and safety of rituximab for adult and geriatric nephrotic patient.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Rate of remission from nephrotic syndrome

Key secondary outcomes

1.Rate of continuity of the selected treatment.
2. The reduction of the degree of proteinuria.
3. Frequency of adverse complication derived from drug use.
4. Total dose of prednisolone and immunosuppressant agents for treatment of nephrotic syndrome.
5. Changes in the renal function


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

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient whose age is more than 18 years old, and who is established the diagnosis of primary nephrotic syndrome.

Key exclusion criteria

Case that showed at least one of the following terms should be excluded.
1)Patient who have the severe allergy for rituximab.
2)Patient who has the severe disease, such as heart failure,liver diseases(hepatitis B positive)and end stage renal disease.
3)Patient who has the severe bacterial,fungal or viral infection.
4)Patient who could not experienced informd consent.
5)The doctor decides that the patient is inappropriate to enroll in this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takasi
Middle name
Last name Takei

Organization

Tokyo Metropolitan Geriatric Hospital

Division name

Nephrology

Zip code

1730015

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan

TEL

03-3964-1982

Email

takashi_takei@tmghig.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Takei

Organization

Tokyo Metropolitan Geriatric Hospital

Division name

Nephrology

Zip code

1730015

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan

TEL

03-3964-1982

Homepage URL


Email

takashi_takei@tmghig.jp


Sponsor or person

Institute

Tokyo Metropolitan Geriatric Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Geriatric Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Metropolitan Geriatric Hospital

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan

Tel

03-3964-1982

Email

takashi_takei@tmghig.jp


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

2016 Year 05 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

2016 Year 04 Month 15 Day

Date of IRB

2016 Year 05 Month 13 Day

Anticipated trial start date

2016 Year 04 Month 30 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 30 Day

Last modified on

2020 Year 05 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name