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

Not Applicable

Terminated

• Conditions: Chronic Rejection
• Interventions: Drug: Deoxyspergualin

• Registration Number: NCT01052259
• Lead Sponsor: Nippon Kayaku Co., Ltd.

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deoxyspergualin, Treatment,	Deoxyspergualin	-

Primary Outcome Measures

Name	Time	Method
Histopathological findings by Banff criteria	6 month after treatment initiation

Secondary Outcome Measures

Name	Time	Method
Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)	6 and 12 months after treatment initiation

Trial Locations

Locations (8)

Gifu University Graduate School of Medicine; 🇯🇵 Gifu, Japan

Graduate School of Medicine Sciences, Kyushu University; 🇯🇵 Fukuoka, Japan

Sapporo City General Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Toda Central General Hospital; 🇯🇵 Toda, Saitama, Japan

Akita University School of Medicine; 🇯🇵 Akita, Japan

Osaka University Graduate School of Medicine; 🇯🇵 Suita, Osaka, Japan

Tokyo Women's Medical University; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Toho University Graduate School of Medicine; 🇯🇵 Ota-ku, Tokyo, Japan