Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/12/2018 |
| Start Date: | August 2016 |
| End Date: | September 2022 |
| Contact: | Abdolreza Haririan, MD, MPH |
| Email: | ahariria@medicine.umaryland.edu |
| Phone: | 410-328-5720 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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1670 University Boulevard
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Phone: 205-934-7220
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