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

NCT02546492 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-10-06

Study results available
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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).

Conditions

  • Transplant Glomerulopathy

Interventions

DRUG

Acthar gel

Administration of the study drug in addition to the current maintenance immunosuppressive agents

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Abdolreza Haririan, MD, MPH · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2021-05-27
Completion
2021-05-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02546492 on ClinicalTrials.gov