Unique ID issued by UMIN | UMIN000000674 |
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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 |
Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin
Cyclosporin A for CIDP
Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin
Cyclosporin A for CIDP
Japan |
Chronic inflammatory demyelinating polyradiculoneuropathy
Neurology |
Others
NO
Evaluation of efficacy and safety of cyclosporin A for chronic demyelinating polyradiculoneuropathy requiring repetitive administration of high-dose intravenous immunoglobulin.
Safety,Efficacy
neurological symptom, frequency of high-dose intravenous immunoglobulin, toxicity
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
Administration of high-dose intravenous immunoglobulin (0.4g/kg) is continued same as observation period.
18 | years-old | <= |
70 | years-old | > |
Male and Female
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
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
50
1st name | |
Middle name | |
Last name | Shu-ichi Ikeda |
Shinshu University School of Medicine
Department of Medicine (Neurology and Rheumatology)
Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
0263-37-2671
1st name | |
Middle name | |
Last name | Shu-ichi Ikeda |
Shinshu University School of Medicine
Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
0263-37-2671
CIDP Study Group
none
Self funding
NO
2007 | Year | 04 | Month | 10 | Day |
Unpublished
2006 | Year | 03 | Month | 23 | Day |
2006 | Year | 08 | Month | 01 | Day |
2008 | Year | 07 | Month | 01 | Day |
2007 | Year | 04 | Month | 10 | Day |
2007 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000810
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