The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.
The primary aim of this study is to investigate the efficacy of deoxyspergualin after the completion of 6 cycles treatment. The efficacy valuables are histological findings in renal grafts, renal function, proteinuria, graft survival, anti-HLA antibody. The safety data are also evaluated in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
100mg/vial as active substance; Deoxyspergualin at 3-5 mg/kg/day by 1-3 iv infusion will be given once a day for 5 to 7 days each cycle every month; Total cycle treatment will be 6.
Akita University School of Medicine
Akita, Akita, Japan
Graduate School of Medicine Sciences, Kyushu University
Fukuoka, Fukuoka, Japan
Gifu University Graduate School of Medicine
Gifu, Gifu, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Histopathological findings by Banff criteria
Time frame: 6 month after treatment initiation
Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)
Time frame: 6 and 12 months after treatment initiation
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Osaka University Graduate School of Medicine
Suita, Osaka, Japan
Toda Central General Hospital
Toda, Saitama, Japan
Toho University Graduate School of Medicine
Ōta-ku, Tokyo, Japan
Tokyo Women's Medical University
Shinjuku-ku, Tokyo, Japan