UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006939 |
|---|---|
| Receipt number | 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 09:17:50 |
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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
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
h-yoko@kanazawa-med.ac.jp
Sponsor or person
Institute
Progressive Renal Diseases Research of the Ministry of Health, Labour and Welfare of Japan, research group of nephrotic syndrome and registry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007975
