Chronic Rejection
Conditions
Keywords
Chronic rejection, Kidney, Transplantation, Immunosuppressive
Brief summary
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.
Detailed description
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.
Interventions
DRUGDeoxyspergualin
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.
Sponsors
Nippon Kayaku Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic rejection defined by Banff 2007 criteria
Exclusion criteria
* Patients who have recurrent renal diseases and virus-associated renal diseases * Patients who have initial WBC \< 4,000, neutrophil \< 1,000 , platelet \< 50,000 or Hb \< 8g * Patients who have acute or chronic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathological findings by Banff criteria | 6 month after treatment initiation |
Secondary
| Measure | Time frame |
|---|---|
| Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE) | 6 and 12 months after treatment initiation |
Countries
Japan
Outcome results
None listed