UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019844 |
|---|---|
| Receipt number | R000022921 |
| Scientific Title | Prospective randomized trial to establish the optimal treatment regimen of rituximab for adult patients with steroid dependent and frequent-relapsing or steroid resistant nephrotic syndrome. |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2015/11/18 16:13:31 |
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Basic information
Public title
Prospective randomized trial to establish the optimal treatment regimen of rituximab for adult patients with steroid dependent and frequent-relapsing or steroid resistant nephrotic syndrome.
Acronym
Prospective randomized trial to compare two treatment regimens of rituximab for adult refractory nephrotic syndrome.
Scientific Title
Prospective randomized trial to establish the optimal treatment regimen of rituximab for adult patients with steroid dependent and frequent-relapsing or steroid resistant nephrotic syndrome.
Scientific Title:Acronym
Prospective randomized trial to compare two treatment regimens of rituximab for adult refractory nephrotic syndrome.
Region
| Japan |
Condition
Condition
Nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to establish the optimal treatment regimen of rituximab for adult patients who have developed nephrotic syndrome at 18 years old or younger and have been steroid-dependent and frequent-relapsing. As a result, it could reduce the number of relapse, extend the duration of complete remission and minimize adverse effects of steroid or immunosuppressive agents.
Additionally, the second aim of this study is to confirm the efficacy and safety of rituximab for patients with adult-onset steroid dependent or resistant nephrotic syndrome who have been complicated with side effects of steroid or immunosuppressive agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Number of relapse (study period:5-7 years)
Key secondary outcomes
1)Duration of complete remission
2)Adverse effect (infusion reaction, anaphylaxis, infectious disease, progressive multifocal leukoencephalopathy, exacerbation of hepatitis and fulminant hepatitis by hepatitis B virus reactivation, skin or mucous membrane symptom, interstitial pneumonia, gastrointestinal perforation or obstruction)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: single dose of rituximab of 375mg/m2 (maximum 500mg) followed by additional single dose every 6 months.
Study period is 5 (minimum)-7 (maximum) years.
Interventions/Control_2
Group B: double doses of rituximab followed the same doses when CD19 positive cell is detected.
Study period is 5 (minimum)-7 (maximum) years.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have developed nephrotic syndrome in 18 years old or younger and have been dependent to steroid alone or in combination with calcineurin inhibitors.
2)Patients who have developed nephrotic syndrome in 19 years old or older and have been dependent or resistant to steroid alone or in combination with calcineurin inhibitors and have been complicated with adverse effect of these drugs (eg. diabetes, morbid fracture).
3)Patients diagnosed by renal biopsy as having minimal change disease or focal segmental glomerulosclerosis.
4)Patients who are at least 20 years old when they gave informed consent.
Key exclusion criteria
1)Patients diagnosed by renal biopsy as having any pathology other than minimal change disease or focal segmental glomerulosclerosis.
2)Patients with malignant disease or hematological disease.
3)Patients who are or may be pregnant, brest-feeding or hope to be pregnant during the study period.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terumasa Hayashi |
Organization
Osaka General Medical Center
Division name
Kidney Disease and Hypertension
Zip code
Address
3-1-56 Bandaihigashi Sumiyoshi-ku Osaka 558-8558, Japan
TEL
81-6-6692-1201
t-hayashi@abelia.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terumasa Hayashi |
Organization
Osaka General Medical Center
Division name
Kidney Disease and Hypertension
Zip code
Address
3-1-56 Bandaihigashi Sumiyoshi-ku Osaka 558-8558, Japan
TEL
81-6-6692-1201
Homepage URL
http://www.gh.opho.jp
t-hayashi@abelia.ocn.ne.jp
Sponsor or person
Institute
Osaka General Medical Center
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
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
大阪府立急性期・総合医療センタ－(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 20 | 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
| 2015 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | 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
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022921
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| Registered date | File name |
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| Registered date | File name |
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