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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010249
Receipt No. 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

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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
Institute Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis
Institute
Department

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
URL(English) https://upload.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


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