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A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

NCT01163799 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-05-03

No results posted yet for this study

Summary

The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.

Conditions

  • Transplant; Failure, Kidney

Interventions

DRUG

Alefacept (ASP0485)

Withdrawal of calcineurin inhibitor at 30 days post-transplant. Administer Alefacept 7.5 mg post-op day 0, post-op day 2 given IV; Alefacept 15 mg SQ X 12 weeks, then monthly until Month 12.

Sponsors & Collaborators

Principal Investigators

  • M. Javeed Ansari, MD · Northwestern Universiy, Northwestern Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163799 on ClinicalTrials.gov