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

N

Nippon Kayaku

Status

Terminated

Conditions

Chronic Rejection

Treatments

Drug: Deoxyspergualin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01052259
SPCR2009

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

11 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Deoxyspergualin, Treatment,
Experimental group
Treatment:
Drug: Deoxyspergualin

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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