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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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:     Hajime Hasegawa
Address:  1981 Kamoda, Kawagoe-shi, Saitama 350-8550, Japan Japan
Telephone: 049-228-3604
Email: hase2126@saitama-med.ac.jp
Affiliation:  The study group of treatment for aged patients with nephrotic syndrome. Affair
Name:     Tetsuya Mitarai
Address:  1981 Kamoda, Kawagoe-shi, Saitama 350-8550, Japan Japan
Telephone: 049-228-3710
Email: mitarai@saitama-med.ac.jp
Affiliation:  Saitama Medical Center, Saitama Medical University Department of Hypertension and kidney disease
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.
Secondary ID(s)
Source(s) of Monetary Support
The Kindney Foundation, Japan
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed: 31/12/2015
URL:
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