The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000008919
• Date of registration: 14/09/2012
• Prospective Registration: Yes
• Primary sponsor: The study group of treatment for aged patients with nephrotic syndrome.
• Public title: The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy.
• Scientific title: The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy. - The study on efficacy and safety of mizoribine for the aged patients with membranous nephropathy.
• Date of first enrolment: 2012/09/15
• Target sample size: 200
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009274
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Tetsuya Mitarai
• Affiliation: Saitama Medical Center, Saitama Medical University Department of Hypertension and kidney disease

• Name: Hajime Hasegawa
• Affiliation: The study group of treatment for aged patients with nephrotic syndrome. Affair

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Case that showed at least one of the following terms should be excluded. 1) Patient who have the allergy for mizoribine. 2) Data of WBC count before entry showed less than 3000/microL. 3) Patient who has the severe disease, such as heart and liver diseases. 4) Patient who has the severe bacterial, fungal or viral infection. 5) Patient who has the relapsed nephrotic syndrome. 6) Patient who experienced kidney transplantation. 7) The doctor decides that the patient is inappropriate to enroll in this study.

Age minimum: 65years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

The patients with nephrotic syndrome due to primary membranous nephropathy.

Intervention(s)

Treatment with a combination of mizoribine plus steroid therapy
Treatment with steroid monotherapy

Primary Outcome(s)

Rate of remission from nephrotic syndrome

Secondary Outcome(s)

1.Rate of continuity of the selected treatment. 2. The reduction of the degree of proteinuria. 3.Frequency of adverse complication derived from drug use. 4.Total dose of corticosteroid for treatment of nephrotic syndrome. 5. Changes in the renal function.

Source(s) of Monetary Support

The Kindney Foundation, Japan

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/12/2015