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NCT02546492 · ClinicalTrials.gov registry record · Phase 4

Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar

A Phase 4 study, sponsored by University of Maryland, Baltimore.

Terminated
Registry status
Phase 4
Development phase
6
Enrollment target

NCT02546492: Clinical Trial Phase 4 study, sponsored by University of Maryland, Baltimore.

NCT02546492 is a Phase 4 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02546492, a Phase 4 study, was terminated before completion, sponsored by University of Maryland, Baltimore.

TERMINATED
Registry status
Phase 4
Development phase
6 participants
Enrollment target

Study Summary

This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody-mediated rejection (CAMR).

Primary Outcome

Participants will be monitored for Serious Adverse Events, as follows (as described in ClinicalTrials.gov) Death, Life-threatening events, Hospitalization (initial or prolonged), Disability and events that requires intervention to prevent permanent impairment or damage. Other (non serious) events which were anticipated or unanticipated (as described in ClinicaTrials.gov) will be monitored. ASSESSMENT: The subjects will be assessed at regular intervals through a questionnaire for Acthar related

Interventions

  • DRUG Acthar gel

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2016-08
Est. Completion 2021-05-27
Phase Phase 4
University of Maryland, Baltimore

560 total trials

Why NCT02546492 stopped before completion

NCT02546492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Acthar gel is the first listed.

NCT02546492 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02546492 about?

NCT02546492 is a clinical study titled "Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar". This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody...

What is the current status of trial NCT02546492?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2016-08. Estimated completion is 2021-05-27.

What interventions are being tested in trial NCT02546492?

The interventions under investigation include: Acthar gel (DRUG).

Who is sponsoring clinical trial NCT02546492?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02546492's enrollment target sits among peer trials

6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT02546492, the US trial registry maintained by the National Library of Medicine. NCT02546492 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.