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

NCT02546492 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HP-00063872
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety (Serious Adverse Events)

  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 events, physician evaluation at clinical visits, and self reporting.

  12 months

Secondary Outcomes (1)

• Efficacy Outcome

  1 year

Study Arms (1)

Acthar

EXPERIMENTAL

The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.

Drug: Acthar gel

Interventions

Acthar gel DRUG

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

Also known as: ACTH (Adrenocorticotropic hormone)

Acthar

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Morphologic diagnosis of CAMR, by light \&/or electron microscopy any time after transplantation
• Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse peritubular capillary C4d staining by immunohistochemistry
• eGFR\>25 ml/min

You may not qualify if:

• Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous basal cell or squamous cell carcinoma).
• Lack of evidence of antibody involvement
• Pregnancy, lactation, or refusal to use birth control in women of child bearing potential
• Active infection, or history of HIV
• History of liver or thoracic transplant

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama School of Medicine, Alabama Transplant Center

Birmingham, Alabama, 35294, United States

Location

Unniversity of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Adrenocorticotropic Hormone

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Only one participant completed the treatment with the study drug Acthar (24 weeks). The other five (5) individuals withdrew from the study early, therefore we are not able to analyze/interpret the efficacy of the study drug.

Results Point of Contact

• Title: A Haririan
• Organization: University of MAryland sSchool of Medicine

ahariria@som.umaryland.edu

410-328-5720

Study Officials

• Abdolreza Haririan, MD, MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director, Kidney and Pancreas Transplant Program

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: September 11, 2015
• Study Start: August 1, 2016
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-10

Locations

US (2)