UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010249
Receipt number R000011996
Scientific Title Effect of leukocyte apheresis for refractory nephrotic syndrome
Date of disclosure of the study information 2013/04/01
Last modified on 2013/03/14 22:01:57

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Basic information

Public title

Effect of leukocyte apheresis for refractory nephrotic syndrome

Acronym

Effect of leukocyte apheresis for refractory nephrotic syndrome

Scientific Title

Effect of leukocyte apheresis for refractory nephrotic syndrome

Scientific Title:Acronym

Effect of leukocyte apheresis for refractory nephrotic syndrome

Region

Japan


Condition

Condition

steroid-resistant nephrotic syndrome

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of leukocyte apheresis for nephrotic syndrome

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

improvement of proteinuria

Key secondary outcomes

renal function, white blood cell count, changes in histology of kidney


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

Device,equipment

Interventions/Control_1

use of leukocyte apheresis

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with steroid-resistant nephrotic syndrome
2) Patients without agreement

Key exclusion criteria

1) Patients with severe heart failure
2) Patients with low blood pressure (systolic blood pressure less than 80mmHg)
3) Patients with white blood cell count of less than 3,000/mm3
4) Patients with anemia (hemoglobin less than 10g/dL)
5) Patients with thrombocytopenia (platelets less than 100,000/mm3)
6) Pregnant patient
7) Patients with drug abuse
8) Patients with cognitive disturbance
9) Patients with anaphylaxis for nafamostat mesilate
10) Patients having received inhibitor of angiotensin converting enzyme
11) Patients judged to be exclusive by investigators with another reason

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kengo Furuichi

Organization

Kanazawa University Hospital

Division name

Division of Blood Purification

Zip code


Address

13-1 Takara-machi, Kanazawa 920-8641, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kanazawa University Hospital

Division name

Division of Blood Purification

Zip code


Address


TEL


Homepage URL


Email

kfuruichi@m-kanazawa.jp


Sponsor or person

Institute

Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis

Institute

Department

Personal name



Funding Source

Organization

None

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

金沢大学附属病院(石川県)


Other administrative information

Date of disclosure of the study information

2013 Year 04 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

Open public recruiting

Date of protocol fixation

2010 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 25 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

2013 Year 03 Month 15 Day

Last modified on

2013 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011996


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name