NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedIgA nephropathy with moderate to severe histological alterations
Date of first enrollment2006/11/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Methylprednisolone pulse therapy followed by oral prednisolone administration Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration

Outcome(s)

Primary OutcomeAltered amounts of proteinuria
Secondary OutcomeAlteration of serum creatinine (SCr) and the slope of reciprocal SCr

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum60years-old
GenderMale and Female
Include criteriaPatients with IgA nephropathy who underwent renal biopsy and provided a written informed consent prior to study by reading and signing the form. 1) Patients who have 5 or more of glomerular score*. 2) Patients who are between 15 and 60 years of age. 3) Patients who have potential to receive methylprednisolone pulse therapy on inpatient basis, and thereafter to receive routine medical treatment as outpatients. *(Katafuchi R et al.Clin Nephrol 49,1998)
Exclude criteria1) 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

Contact

public contact
Name Kosuke Masutani
Address Maidashi 3-1-1, Higashi-ku, Fukuoka Japan
Telephone 092-642-5843
E-mail 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
E-mail tsuruya@intmed2.med.kyushu-u.ac.jp
Affiliation Graduate School of Medical Sciences, Kyushu University Department of Integrated Therapy for Chronic Kidney Disease