NCT01052259

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

3.5 years

First QC Date

January 14, 2010

Last Update Submit

January 7, 2014

Conditions

Chronic Rejection

Keywords

Chronic rejectionKidneyTransplantationImmunosuppressive

Outcome Measures

Primary Outcomes (1)

  • Histopathological findings by Banff criteria

    6 month after treatment initiation

Secondary Outcomes (1)

  • Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)

    6 and 12 months after treatment initiation

Study Arms (1)

Deoxyspergualin, Treatment,

EXPERIMENTAL
Drug: Deoxyspergualin

Interventions

DeoxyspergualinDRUG

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.

Also known as: Spanidin, gusperimus hydrochloride
Deoxyspergualin, Treatment,

Eligibility Criteria

Age11 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic rejection defined by Banff 2007 criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Akita University School of Medicine

Akita, Akita, 010-8543, Japan

Location

Graduate School of Medicine Sciences, Kyushu University

Fukuoka, Fukuoka, 812-8582, Japan

Location

Gifu University Graduate School of Medicine

Gifu, Gifu, 501-1194, Japan

Location

Sapporo City General Hospital

Sapporo, Hokkaido, 060-8604, Japan

Location

Osaka University Graduate School of Medicine

Suita, Osaka, 565-0871, Japan

Location

Toda Central General Hospital

Toda, Saitama, 335-0023, Japan

Location

Toho University Graduate School of Medicine

Ōta-ku, Tokyo, 143-8541, Japan

Location

Tokyo Women's Medical University

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

MeSH Terms

Interventions

gusperimus

Study Officials

  • Hiroshi Harada, Chief

    Sapporo City General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 20, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

JP(8)