NCT01052259

Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection

Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Nippon Kayaku Co., Ltd. · Industry
• Sex: All
• Age: 11 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rejection

Interventions

Type	Name	Description
DRUG	Deoxyspergualin	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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-01-20
• Last updated: 2014-01-08

Locations

8 sites across 1 country: Japan