Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin

UMIN ID: UMIN000000674

Registered date:10/04/2007

Basic Information

• Health condition(s) or Problem(s) studied: Chronic inflammatory demyelinating polyradiculoneuropathy
• Date of first enrollment: 2006/08/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: neurological symptom, frequency of high-dose intravenous immunoglobulin, toxicity

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: CIDP Study Group
• Source(s) of Monetary Support: none