UMIN ID: C000000368
Registered date:27/03/2006
Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | membranous nephropathy with primary steroid resistant nephrotic syndrome |
Date of first enrollment | 2004/04/01 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | mizoribine once a day per os administration (150mg) after breakfast for 2years. mizoribine 3 times a day per os administration (50mg each) after meals for 2years. |
Outcome(s)
Primary Outcome | urine protein excretion (g/day) remission status of nephrotic syndrome |
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Secondary Outcome | renal function (creatinine clearance (Ccr)) serum total protein and albumin levels |
Key inclusion & exclusion criteria
Age minimum | 16years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) The subject presents with renal dysfunction (Ccr less than 50mL/min or serum creatinine more than 2mg/dL. 2) The subject previously had serious hypersensitivity to mizoribine. 3) The subject's white blood cells are under 3000/mm3. 4) The subject is currently pregnant, is supposed to be pregnant, plans to become pregnant during the study period, or is nursing. 5) The subject has serious complications. 6) The subject has serious infections by bacteria, fungus or virus. 7) The subject has already been treated with mizoribine at the study commencement. 8) The subject is inappropriate for participation in the study as determined by an investigator. |
Related Information
Primary Sponsor | Project team for treatment of refractory nephrotic syndrome |
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Secondary Sponsor | The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan |
Source(s) of Monetary Support | Japan Kidney Foundation |
Secondary ID(s) |
Contact
public contact | |
Name | Takao Saito |
Address | 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan Japan |
Telephone | 092-801-1011ext.3374 |
tsaito@fukuoka-u.ac.jp | |
Affiliation | Project team for refractory nephrotic syndrome Division of Nephrology and Rheumatology, Fukuoka University Hospital |
scientific contact | |
Name | Takao Saito |
Address | 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan Japan |
Telephone | 092-801-1011 |
tsaito@fukuoka-u.ac.jp | |
Affiliation | Project team for treatment of refractory nephrotic syndrome Division of Nephrology and Rheumatology, Department of Internal Medicine, Fukuoka University School of Medicine |