Randomized controlled trial of mizoribine for progressive IgA nephropathy

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000000593
• Date of registration: 05/02/2007
• Prospective Registration: No
• Primary sponsor: West Japan Study Group for Therapy of IgA Nephropathy
• Public title: Randomized controlled trial of mizoribine for progressive IgA nephropathy
• Scientific title: Randomized controlled trial of mizoribine for progressive IgA nephropathy - Randomized controlled trial of mizoribine for progressive IgA nephropathy
• Date of first enrolment: 2006/11/01
• Target sample size: 120
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000675
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Kosuke Masutani
• Affiliation: West Japan Study Group for Therapy of IgA Nephropathy Kidney Care Unit, Kyushu University Hospital

• Name: Kazuhiko Tsuruya
• Affiliation: Graduate School of Medical Sciences, Kyushu University Department of Integrated Therapy for Chronic Kidney Disease

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion 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

Age minimum: 15years-old
Age maximum: 60years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

IgA nephropathy with moderate to severe histological alterations

Intervention(s)

Methylprednisolone pulse therapy followed by oral prednisolone administration
Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration

Primary Outcome(s)

Altered amounts of proteinuria

Secondary Outcome(s)

Alteration of serum creatinine (SCr) and the slope of reciprocal SCr

Source(s) of Monetary Support

The Kidney Foundation, Japan

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/10/2010
• URL: https://www.ncbi.nlm.nih.gov/pubmed/26758039