Purpose

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 (2 g/Kg), and/or Rituximab, in patients with CAMR.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acthar
The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.
  • Drug: Acthar gel
    Administration of the study drug in addition to the current maintenance immunosuppressive agents
    Other names:
    • ACTH

Recruiting Locations

Unniversity of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Lalitha Anandagoda, MPH
410-328-5720
laanandagoda@som.umaryland.edu

More Details

NCT ID
NCT02546492
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Abdolreza Haririan, MD, MPH
410-328-5720
ahariria@medicine.umaryland.edu

Detailed Description

Subjects will receive Acthar® 40 units twice a week subcutaneously for 2 weeks. If the drug is well tolerated the dose will be increased to 80 units twice a week for another 22 weeks. The patients will be maintained on their center-specific standard maintenance regimen, typically consisting of Tacrolimus, mycephenolate mofetil/Sodium, and prednisone.

After screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study. The initial visit and subsequent study-related visits at 4, 8, 12, 24, 36 and 52 weeks will include routine evaluation and physical examination and laboratory studies including CBC, electrolyte panel, eGFR, albumin, liver enzymes, and CNI/sirulimus drug level, according to the center's standard of care. DSA will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care. The biopsies will be evaluated by light and electron microscopy using standard histological Banff criteria, and staining for CD68.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.