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

This study has been terminated.
(Insufficient patient enrollment)
Sponsor:
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01052259
First received: January 14, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Rejection
Drug: Deoxyspergualin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • Histopathological findings by Banff criteria [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE) [ Time Frame: 6 and 12 months after treatment initiation ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deoxyspergualin, Treatment, 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.
Other Name: Spanidin, gusperimus hydrochloride

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.

  Eligibility

Ages Eligible for Study:   11 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052259

Locations
Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan, 060-8604
Osaka University Graduate School of Medicine
Suita, Osaka, Japan, 565-0871
Toda Central General Hospital
Toda, Saitama, Japan, 335-0023
Toho University Graduate School of Medicine
Ota-ku, Tokyo, Japan, 143-8541
Tokyo Women's Medical University
Shinjuku-ku, Tokyo, Japan, 162-8666
Akita University School of Medicine
Akita, Japan, 010-8543
Graduate School of Medicine Sciences, Kyushu University
Fukuoka, Japan, 812-8582
Gifu University Graduate School of Medicine
Gifu, Japan, 501-1194
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Investigators
Principal Investigator: Hiroshi Harada, Chief Sapporo City General Hospital
  More Information

No publications provided

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01052259     History of Changes
Other Study ID Numbers: SPCR2009
Study First Received: January 14, 2010
Last Updated: January 7, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Nippon Kayaku Co.,Ltd.:
Chronic rejection
Kidney
Transplantation
Immunosuppressive

Additional relevant MeSH terms:
Gusperimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014