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
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
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
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
