Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Nippon Kayaku Co.,Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Nippon Kayaku Co.,Ltd.
Information provided by:
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01052259
First received: January 14, 2010
Last updated: November 2, 2010
Last verified: January 2010
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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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | December 2011 (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
Contacts
| Contact: Hiroshi Harada, Chief | +81117262211 | hiroshi.harada@doc.city.sapporo.jp |
Locations
| Japan | |
| Sapporo City General Hospital | Recruiting |
| Sapporo, Hokkaido, Japan, 060-8604 | |
| Contact: Hiroshi Harada, Chief +81117262211 hiroshi.harada@doc.city.sapporo.jp | |
| Principal Investigator: Hiroshi Harada, Chief | |
| Osaka University Graduate School of Medicine | Recruiting |
| Suita, Osaka, Japan, 565-0871 | |
| Contact: Shiro Takahara, Professor +81668793746 takahara@att.med.osaka-u.ac.jp | |
| Contact: Koji Yazawa, Asst Prof +81668793531 yazawa@uro.med.osaka-u.ac.jp | |
| Principal Investigator: Shiro Takahara, Professor | |
| Sub-Investigator: Koji Yazawa, Asst Professor | |
| Toda Central General Hospital | Active, not recruiting |
| Toda, Saitama, Japan, 335-0023 | |
| Toho University Graduate School of Medicine | Recruiting |
| Ota-ku, Tokyo, Japan, 143-8541 | |
| Contact: Atsushi Aikawa, Professor +81337624151 aaikawa@med.toho-u.ac.jp | |
| Principal Investigator: Atsushi Aikawa, Professor | |
| Tokyo Women's Medical University | Active, not recruiting |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Akita University School of Medicine | Not yet recruiting |
| Akita, Japan, 010-8543 | |
| Contact: Shigeru Sato, Professor +81188846239 shigerus@doc.med.akita-u.ac.jp | |
| Principal Investigator: Shigeru Sato, Professor | |
| Graduate School of Medicine Sciences, Kyushu University | Not yet recruiting |
| Fukuoka, Japan, 812-8582 | |
| Contact: Hidehisa Kitada, Assistant Professor +81926425443 hide@surg1.med.kyushu-u.ac.jp | |
| Contact: Kohsuke Masutani, Assistant Professor +81926425843 masutani@kcu.med.kyushu-u.ac.jp | |
| Principal Investigator: Hidehisa Kitada, Asst Prof | |
| Sub-Investigator: Kohsuke Masutani, Asst Prof | |
| Gifu University Graduate School of Medicine | Recruiting |
| Gifu, Japan, 501-1194 | |
| Contact: Shinichi Ito, Ass Prof +81 58 230 6000 ext 7738 boxter@gifu-u.ac.jp | |
| Principal Investigator: Shinichi Ito, Ass Prof | |
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Investigators
| Principal Investigator: | Hiroshi Harada, Chief | Sapporo City General Hospital |
More Information
No publications provided
| Responsible Party: | Kyuichi Nemoto, Section Manager of Worldwide Clinical Development, Nippon Kayaku Co. Ltd |
| ClinicalTrials.gov Identifier: | NCT01052259 History of Changes |
| Other Study ID Numbers: | SPCR2009 |
| Study First Received: | January 14, 2010 |
| Last Updated: | November 2, 2010 |
| 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 May 19, 2013