UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000674 |
|---|---|
| Receipt number | R000000810 |
| Scientific Title | Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin |
| Date of disclosure of the study information | 2007/04/10 |
| Last modified on | 2007/04/10 12:02:00 |
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Basic information
Public title
Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin
Acronym
Cyclosporin A for CIDP
Scientific Title
Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin
Scientific Title:Acronym
Cyclosporin A for CIDP
Region
| Japan |
Condition
Condition
Chronic inflammatory demyelinating polyradiculoneuropathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of cyclosporin A for chronic demyelinating polyradiculoneuropathy requiring repetitive administration of high-dose intravenous immunoglobulin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neurological symptom, frequency of high-dose intravenous immunoglobulin, toxicity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cyclosporin A is given orally at an initial dose of 3 mg/kg/day. The dosage of cyclosporine A is adjusted to keep a serum trough concentration between 100 and 150 ng/ml. Adiministration of high-dose intravenous immunoglobulin (0.4g/kg)is continued same as observation period.
Interventions/Control_2
Administration of high-dose intravenous immunoglobulin (0.4g/kg) is continued same as observation period.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Definite or probable CIDP according to classification criteria of the EFNS/PNS CIDP guideline.
2. Exacerbations more than 4 times per year.
3. INCAT disability scale higher than grade 2 in upper limbs or grade 1 in lower limbs.
4. Written informed consent
Key exclusion criteria
1. polyneuropathy of other causes
2. multifocal motor neuropathy
3. positive for anti-MAG antibody
4. treated with prednisolone at a dose higher than 30 mg/day
5. previous history of cyclosporin A
6. neuron-Behcet
7. malignancy
8. chronic active inflammatory diseases
9. poor-controlled hypertension
10. congestive heart failure
11. liver cirrhosis
12. nephritic syndrome
13. hyperkalemia
14. gout
15. diabetes mellitus
16. pancreatitis
17. severe central nervous disorders
18. pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shu-ichi Ikeda |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine (Neurology and Rheumatology)
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-2671
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu-ichi Ikeda |
Organization
Shinshu University School of Medicine
Division name
Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
Zip code
Address
TEL
0263-37-2671
Homepage URL
Sponsor or person
Institute
CIDP Study Group
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 04 | Month | 10 | 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
Date of protocol fixation
| 2006 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 10 | Day |
Last modified on
| 2007 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000810
