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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006939
Receipt No. R000007975
Scientific Title High-dose gamma-globulin therapy for nephrotic membranous nephropathy patients
Date of disclosure of the study information 2012/01/30
Last modified on 2018/12/29

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Basic information
Public title High-dose gamma-globulin therapy for nephrotic membranous nephropathy patients
Acronym HIGHNESS study
Scientific Title High-dose gamma-globulin therapy for nephrotic membranous nephropathy patients
Scientific Title:Acronym HIGHNESS study
Region
Japan

Condition
Condition membranous nephropathy, nephrotic syndrome
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of immunoglobulin for membranaous nephtopathy.
Prevention of infectious diseases in nephrotic membranous patients.
Spontaneous remission rate of membranous nephropahty in Japanese.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Remission rate of complete or incomplete type 1
Key secondary outcomes Alteration of proteinuria or renal function
Compliction of infectious diseases or cardiovascular diseases
Spontaneous remission rate in natural clinical course

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Immunoglobulin
Interventions/Control_2 ARB or ACEi with or without Statin
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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Nephrotic membranous nephropathy
Key exclusion criteria Secondary membranous nephropathy
Diabetic patients
Recent cardiovascular accidents within 6 months
Malignancy
Liver diseases
Patients treated with immunosuppressive therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Matsuo
Organization Progressive Renal Diseases Research of the Ministry of Health, Labour and Welfare of Japan
Division name Research Group of Nephrotic syndrome
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, 466-8550
TEL 052-744-2192
Email h-yoko@kaanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Yokoyama
Organization Kanazawa Medical University Hospital
Division name Nephrology
Zip code
Address 1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL 076-286-2211(3401)
Homepage URL
Email h-yoko@kanazawa-med.ac.jp

Sponsor
Institute Progressive Renal Diseases Research of the Ministry of Health, Labour and Welfare of Japan, research group of nephrotic syndrome and registry
Institute
Department

Funding Source
Organization Progressive Renal Diseases Research of the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Teijin Pharmacological Co

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
2012 Year 01 Month 30 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 Terminated
Date of protocol fixation
2011 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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
2011 Year 12 Month 24 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007975

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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