UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055113 |
|---|---|
| Receipt number | R000062955 |
| Scientific Title | Systematic review and meta-analysis for the 2026 update of the Japanese clinical practice guidelines for the management of membranous nephropathy |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/08/03 01:43:28 |
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Basic information
Public title
Systematic review and meta-analysis for the 2026 update of the Japanese clinical practice guidelines for the management of membranous nephropathy
Acronym
Membranous nephropathy CPG update 2026
Scientific Title
Systematic review and meta-analysis for the 2026 update of the Japanese clinical practice guidelines for the management of membranous nephropathy
Scientific Title:Acronym
Membranous nephropathy CPG update 2026
Region
| Japan |
Condition
Condition
Idiopathic membranous nephrooathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Update the Nephrotic Syndrome Clinical Practice Guidelines in 2026 as part of the Intractable Disease Policy Research Project.
A systematic review and meta-analysis of drug therapy for membranous nephropathy will be conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total death
Renal death (dialysis induction or renal transplantation)
Development of infection
Recurrence of nephrosis
Nephrotic remission (complete or incomplete)
Decline in renal function (sCr or CCr or GFR)
Quality of Life
Length of hospital stay, number of hospitalizations
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
randomized control trials
Key exclusion criteria
Secondary membranous nephropathy
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sofue |
Organization
Kagawa University
Division name
Department of Cardiorenal and Cerebrovascular Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-Chou, Kida-Gun, Kagawa, Japan
TEL
0878985111
sofue.tadashi@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishiwaki |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
2278501
Address
1-30, Fujigaoka, Aoba, Yokohama, Japan
TEL
+81-45-971-1151
Homepage URL
nwacky1978@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Hiroki Nishiwaki
Funding Source
Organization
MHLW Grants-in-Aid for Scientific Research on Intractable Diseases Policy Research Project.
Research on Intractable Renal Failure Clinical Practice Guideline Working Group
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
not applicable
Address
not applicable
Tel
+81-45-971-1151
nwacky1978@med.showa-u.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
| 2024 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eligibility criteria include randomized controlled trials of the following agents in patients with idiopathic membranous nephropathy
Control drugs: corticosteroid, chlorambucil, cyclophosphamide (including POCY and IVCY, but treated separately later), cyclosporine, Tacrolimus, Mofetil mycophenolate(including EC-MPS, treated separately later), mizoribine, Azathioprine, ACTH, Leflunomide, Rituximab, Ofatumumab, Ocrelizumab, Obinutuzumab, Zanubrutinib, Felzartamab, Belimumab, Iptacopan
Outcomes: all-cause mortality, renal death (dialysis induction or renal transplantation), development of infection, nephrotic recurrence, nephrotic remission (complete or incomplete), renal function decline (sCr or CCr or GFR), quality of life*, length of hospital stay, number of hospitalizations, other adverse effects
A review search of MEDLINE (via pubmed) and medical journals will be performed for literature published since 2016 for idiopathic membranous nephropathy; for literature published before 2016, literature used in the Nephrotic Syndrome Practice Guidelines 2020 will be included. Selected references will be screened by at least two persons using the title and abstract. The full text of the selected articles will then be screened by at least two reviewers. Data extraction and risk-of-bias assessment will be conducted on the selected articles by at least two reviewers. Conduct a network meta-analysis.
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062955
