Clinical trial NCT02546492: Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Official title: Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Transplant Glomerulopathy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2015-09-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 (complete blood count), electrolyte panel, eGFR, albumin, liver enzymes, and Calcineurin inhibitor (CNI)/sirolimus drug level, according to the center's standard of care. Donor-specific antibody (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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety (Serious Adverse Events)
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy Outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama School of Medicine, Alabama Transplant Center
state: Alabama
city: Baltimore
country: United States
facility: Unniversity of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Abdolreza Haririan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: