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

Transplant Glomerulopathy Clinical Trial

— TGActhar  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02546492
• Other study ID #: HP-00063872
• Status: Terminated
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: May 27, 2021

Study information

• Verified date: October 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Transplant Glomerulopathy

Intervention

Drug:
• Acthar gel
Administration of the study drug in addition to the current maintenance immunosuppressive agents

Locations

Country	Name	City	State
United States	Unniversity of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama School of Medicine, Alabama Transplant Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy Outcome	composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria	1 year