UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038242 |
|---|---|
| Receipt number | R000043592 |
| Scientific Title | The effect of Evolocumab on primary nephrotic syndrome |
| Date of disclosure of the study information | 2019/10/09 |
| Last modified on | 2022/10/10 10:49:33 |
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Basic information
Public title
The effect of Evolocumab on primary nephrotic syndrome
Acronym
The effect of Evolocumab on primary nephrotic syndrome
Scientific Title
The effect of Evolocumab on primary nephrotic syndrome
Scientific Title:Acronym
The effect of Evolocumab on primary nephrotic syndrome
Region
| Japan |
Condition
Condition
Primary nephrotic syndrome
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary nephrotic syndrome can be refractory, and the risk of complications rises with prolonged remission induction. Increase of the remission induction rate and a reduction in the remission induction period are expected.
High LDL cholesterol level may inhibit remission induction, but statins sometimes do not effect very much.
In this study, we investigate the clinical effects of improving LDL cholesterol level with Evolocumab for primary nephrotic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission rate
Key secondary outcomes
Remission introduction period, cumulative dose of prednisolone and immunosuppressant agents, reduction of the degree of proteinuria, change of serum albumin, adverse complication derived from prednisolone and immunosuppressant agents use, 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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Evolocumab
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as primary nephrotic syndrome
2) High LDL cholesterol
3) Men and women aged 16 or older when obtaining consent
4) Written consent has been obtained from the patient or family member to participate in the study.
5) Dyslipidemia patient resistant to HMG-CoA reductase inhibitors or patient who cannot use HMG-CoA reductase inhibitors because of allergies, vomiting, dyspnea, etc.
Key exclusion criteria
1) Pregnant women
2) Secondary nephrotic syndrome
3) Clearly nephrotoxic treatment is undergoing
4) Patient judged inappropriate by the examining physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Asai |
Organization
Nippon Medical School Tamanagayama Hospital
Division name
Department of Nephrology
Zip code
206-8512
Address
1-7-1 Nagayama, Tama-shi, Tokyo
TEL
042-371-2111
rasai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Asai |
Organization
Department of Nephrology, Nippon Medical School
Division name
Department of Nephrology
Zip code
206-8512
Address
1-7-1 Nagayama, Tama-shi, Tokyo
TEL
042-371-2111
Homepage URL
rasai@nms.ac.jp
Sponsor or person
Institute
Department of Nephrology, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Tamanagayama Hospital
Address
1-7-1 Nagayama, Tama-shi, Tokyo
Tel
042-371-2111
rasai@nms.ac.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
| 2019 | Year | 10 | Month | 09 | 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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043592
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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