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NCT01856257 · ClinicalTrials.gov registry record · Phase 2

Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Terminated
Registry status
Phase 2
Development phase
71
Enrollment target

NCT01856257 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 71 participants.

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The verdict

NCT01856257, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

TERMINATED
Registry status
Phase 2
Development phase
71 participants
Enrollment target

Study Summary

The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.

Interventions

  • DRUG methylprednisolone
  • BIOLOGICAL belatacept
  • DRUG mycophenolate mofetil
  • BIOLOGICAL basiliximab
  • BIOLOGICAL Anti-thymocyte Globulin (Rabbit)

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2013-07
Est. Completion 2016-04
Phase Phase 2

What the Registry Record Tells You About NCT01856257

The ClinicalTrials.gov registry entry for NCT01856257 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.

NCT01856257 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01856257 about?

NCT01856257 is a clinical study titled "Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen". The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.

What is the current status of trial NCT01856257?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2013-07. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01856257?

The interventions under investigation include: methylprednisolone (DRUG), belatacept (BIOLOGICAL), mycophenolate mofetil (DRUG), basiliximab (BIOLOGICAL), Anti-thymocyte Globulin (Rabbit) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01856257?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.