Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-C000000368
• Date of registration: 27/03/2006
• Prospective Registration: No
• Primary sponsor: Project team for treatment of refractory nephrotic syndrome
• Public title: Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome
• Scientific title: Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome - Combined therapy of prednisolone and mizoribine in membranous nephropathy with refractory nephrotic syndrome
• Date of first enrolment: 2004/04/01
• Target sample size: 100
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000462
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Takao Saito
• Affiliation: Project team for refractory nephrotic syndrome Division of Nephrology and Rheumatology, Fukuoka University Hospital

• Name: Takao Saito
• Affiliation: Project team for treatment of refractory nephrotic syndrome Division of Nephrology and Rheumatology, Department of Internal Medicine, Fukuoka University School of Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion 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.

Age minimum: 16years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

membranous nephropathy with primary steroid resistant nephrotic syndrome

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.

Primary Outcome(s)

urine protein excretion (g/day) remission status of nephrotic syndrome

Secondary Outcome(s)

renal function (creatinine clearance (Ccr)) serum total protein and albumin levels

Source(s) of Monetary Support

Japan Kidney Foundation

Secondary Sponsor(s)

The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/12/2009