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NCT01163799 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Northwestern University.

Terminated
Registry status
Phase 1
Development phase
9
Enrollment target

NCT01163799: Clinical Trial Phase 1 study, sponsored by Northwestern University.

NCT01163799 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01163799, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

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

Primary Outcome

To assess the safety and efficacy of alefacept in combination with a single dose of alemtuzamab induction and Enteric coated Mycophenolic sodium with calcineurin inhibitor withdrawal and rapid elimination of corticosteroids by examining the incidence of first biopsy-proven acute rejection (Banff Grade≥ 1) (BCAR rate) and the incidence and clinical presentation of infections.

Interventions

  • DRUG Alefacept (ASP0485)

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2010-07
Est. Completion 2012-08
Phase Phase 1
Northwestern University

1,209 total trials

Why NCT01163799 stopped before completion

NCT01163799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which Alefacept (ASP0485) is the first listed.

NCT01163799 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01163799 about?

NCT01163799 is a clinical study titled "A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients". The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.

What is the current status of trial NCT01163799?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-07. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01163799?

The interventions under investigation include: Alefacept (ASP0485) (DRUG).

Who is sponsoring clinical trial NCT01163799?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01163799's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01163799, the US trial registry maintained by the National Library of Medicine. NCT01163799 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.