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

Chronic Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01052259
• Other study ID #: SPCR2009
• Status: Terminated
• Phase: N/A
• First received: January 14, 2010
• Last updated: January 7, 2014
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Nippon Kayaku Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rejection

Intervention

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.

Locations

Country	Name	City	State
Japan	Akita University School of Medicine	Akita
Japan	Graduate School of Medicine Sciences, Kyushu University	Fukuoka
Japan	Gifu University Graduate School of Medicine	Gifu
Japan	Toho University Graduate School of Medicine	Ota-ku	Tokyo
Japan	Sapporo City General Hospital	Sapporo	Hokkaido
Japan	Tokyo Women's Medical University	Shinjuku-ku	Tokyo
Japan	Osaka University Graduate School of Medicine	Suita	Osaka
Japan	Toda Central General Hospital	Toda	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Nippon Kayaku Co.,Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathological findings by Banff criteria		6 month after treatment initiation	No
Secondary	Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)		6 and 12 months after treatment initiation	Yes