Efficacy and Safety of Deoxyspergualin in Renal Transplan... | NCT01052259

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

NCT01052259

Sponsor

Nippon Kayaku Co., Ltd.

Status

Terminated

Last Update Posted

Jan 8, 2014Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Chronic Rejection

Interventions

Deoxyspergualin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient patient enrollment

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2014

Last Update Posted Date

Jan 8, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deoxyspergualin, Treatment,	Experimental		Drug: Deoxyspergualin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deoxyspergualin	Drug	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Harada, Chief	Sapporo City General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akita University School of Medicine		Akita	Akita	010-8543	Japan
Graduate School of Medicine Sciences, Kyushu University

Intervention Browse Module

MeSH Terms

ID	Term
C037258	gusperimus

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided