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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000368

Enrollment

100

Registered

2006-03-27

Start date

2004-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

membranous nephropathy with primary steroid resistant nephrotic syndrome

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Membranous nephropathy is diagnosed by renal biopsy. 2) The subject's urine protein excretion is more than 3.5g/day and serum albumin level is less than 3.0/dL before the treatment. In addition, corticosteroids treatment for more than 4 weeks has not reduced the subject's urine protein excretion less than 1g/day before the study commencement. 3) The subject is a male or female between 16 and 75 years of age. 4) The subject has voluntarily signed a document of the informed consent.

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
urine protein excretion (g/day) remission status of nephrotic syndrome	—

Secondary

Measure	Time frame
renal function (creatinine clearance (Ccr)) serum total protein and albumin levels	—

Countries

Japan

Contacts

Public ContactTakao Saito

Project team for refractory nephrotic syndrome Division of Nephrology and Rheumatology, Fukuoka University Hospital

tsaito@fukuoka-u.ac.jp092-801-1011ext.3374

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026