UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062267 |
|---|---|
| Receipt number | R000071238 |
| Scientific Title | A Cohort Study of Intravenous Immunoglobulin Dosing Interval Adherence in Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy Using Japanese Real-World Data |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 13:54:08 |
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Basic information
Public title
A Study of Infusion Treatment Intervals in Patients Receiving Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Acronym
CIDP-IVIG Interval Study
Scientific Title
A Cohort Study of Intravenous Immunoglobulin Dosing Interval Adherence in Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy Using Japanese Real-World Data
Scientific Title:Acronym
CIDP-IVIG Interval Study
Region
| Japan |
Condition
Condition
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize adherence to IVIG dosing intervals in maintenance therapy for CIDP in routine clinical practice.
Basic objectives2
Others
Basic objectives -Others
To explore the association between adherence to IVIG dosing intervals in maintenance therapy for CIDP and patient characteristics, treatment patterns, and comorbidities in routine clinical practice.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
As a measure of adherence to the administered IVIG dosing interval, the proportion of days covered (PDC) will be assessed during the periods from the index date to Week 12, Weeks 13-24, Weeks 25-48, and Weeks 49-96.
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A confirmed diagnosis of CIDP was recorded during the calendar month including the first day of the IVIG induction therapy cycle or within the preceding 6 months.
2. A nerve conduction study was recorded during the calendar month including the first day of the IVIG induction therapy cycle or within the preceding 6 months.
3. The patient was aged 18 years or older on the first day of the IVIG induction therapy cycle.
Key exclusion criteria
Patients who had a confirmed diagnosis (excluding suspected diagnoses) of an autoimmune neuropathy requiring differential diagnosis from CIDP during the calendar month including the first day of the IVIG induction therapy cycle (inclusive) or within the preceding 6 months. For the purposes of this study, the following conditions are considered autoimmune neuropathies:
-Multifocal motor neuropathy(MMN)
-Guillain-Barre syndrome (GBS)
-Fisher syndrome
-Anti-myelin-associated glycoprotein (anti-MAG) neuropathy
-POEMS syndrome
-Paraneoplastic neurological syndrome and Lambert-Eaton myasthenic syndrome (LEMS}
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Tomizawa |
Organization
Juntendo University
Division name
Department of Neurology, Faculty of Medicine and Graduate School of Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3813-3111
zawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Doi |
Organization
CSL Behring K.K.
Division name
Medical Affairs
Zip code
107-0061
Address
1-2-3 Kita-Aoyama, Minato-ku, Tokyo
TEL
0120-534-587
Homepage URL
JPN.Medical_Affairs@cslbehring.com
Sponsor or person
Institute
CSL Behring K.K.
Institute
Department
Personal name
Funding Source
Organization
CSL Behring K.K.
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
None
Address
None
Tel
+81 (--) ---- -----
none@none.org
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
| 2026 | Year | 07 | Month | 17 | 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
| 2026 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis using an existing database containing anonymized information
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071238
