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

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ClinicalTrials.gov Identifier: NCT01052259
Recruitment Status : Terminated (Insufficient patient enrollment)
First Posted : January 20, 2010
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Rejection Drug: Deoxyspergualin Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation
Study Start Date : June 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Histopathological findings by Banff criteria [ Time Frame: 6 month after treatment initiation ]

Secondary Outcome Measures :
  1. Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE) [ Time Frame: 6 and 12 months after treatment initiation ]


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Ages Eligible for Study:   11 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01052259     History of Changes
Other Study ID Numbers: SPCR2009
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

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

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