NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedmembranous nephropathy with primary steroid resistant nephrotic syndrome
Date of first enrollment2004/04/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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 Outcomeurine protein excretion (g/day) remission status of nephrotic syndrome
Secondary Outcomerenal function (creatinine clearance (Ccr)) serum total protein and albumin levels

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Takao Saito
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan Japan
Telephone 092-801-1011ext.3374
E-mail 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
E-mail 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