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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000674
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute CIDP Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000810

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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