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

January 7, 2014 updated by: Nippon Kayaku Co., Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan, 010-8543
        • Akita University School of Medicine
      • Fukuoka, Japan, 812-8582
        • Graduate School of Medicine Sciences, Kyushu University
      • Gifu, Japan, 501-1194
        • Gifu University Graduate school of Medicine
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8604
        • Sapporo City General Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Graduate School of Medicine
    • Saitama
      • Toda, Saitama, Japan, 335-0023
        • Toda Central General Hospital
    • Tokyo
      • Ota-ku, Tokyo, Japan, 143-8541
        • Toho University Graduate School of Medicine
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Spanidin, gusperimus hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histopathological findings by Banff criteria
Time Frame: 6 month after treatment initiation
6 month after treatment initiation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nippon Kayaku Co., Ltd.

Investigators

  • Principal Investigator: Hiroshi Harada, Chief, Sapporo City General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPCR2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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