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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deoxyspergualin, Treatment,

Group Type EXPERIMENTAL

Deoxyspergualin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Spanidin, gusperimus hydrochloride

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No