UMIN ID: UMIN000000593
Registered date:05/02/2007
Randomized controlled trial of mizoribine for progressive IgA nephropathy
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | IgA nephropathy with moderate to severe histological alterations |
Date of first enrollment | 2006/11/01 |
Target sample size | 120 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Methylprednisolone pulse therapy followed by oral prednisolone administration Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration |
Outcome(s)
Primary Outcome | Altered amounts of proteinuria |
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Secondary Outcome | Alteration of serum creatinine (SCr) and the slope of reciprocal SCr |
Key inclusion & exclusion criteria
Age minimum | 15years-old |
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Age maximum | 60years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Patients who have been treated with corticosteroids or mizoribine already 2) Patients who suffered infectious diseases such as pneumonia 3) Patients whose white blood cells count is under 3,000/mm3 4) Patients who are demonstrated to have another renal disease on renal biopsy 5) Patients who have diabetes mellitus 6) Patients who are have severe heart or liver disease 7) Patients who have malignant tumors 8) Patients who are currently pregnant or are supposed to be pregnant 9) Patients who are judged to be inappropriate for participation in this study by an physician |
Related Information
Primary Sponsor | West Japan Study Group for Therapy of IgA Nephropathy |
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Secondary Sponsor | |
Source(s) of Monetary Support | The Kidney Foundation, Japan |
Secondary ID(s) |
Contact
public contact | |
Name | Kosuke Masutani |
Address | Maidashi 3-1-1, Higashi-ku, Fukuoka Japan |
Telephone | 092-642-5843 |
masutani@kcu.med.kyushu-u.ac.jp | |
Affiliation | West Japan Study Group for Therapy of IgA Nephropathy Kidney Care Unit, Kyushu University Hospital |
scientific contact | |
Name | Kazuhiko Tsuruya |
Address | Maidashi 3-1-1, Higashi-ku, Fukuoka Japan |
Telephone | 092-642-5843 |
tsuruya@intmed2.med.kyushu-u.ac.jp | |
Affiliation | Graduate School of Medical Sciences, Kyushu University Department of Integrated Therapy for Chronic Kidney Disease |