ACTHar gel
ACTHar Gel is a long-acting formulation of adrenocorticotropic hormone. ACTHar gel binds to melanocortin receptors in a variety of cell types including immune cells. Melanocortin receptor (MCR) activation is responsible for the steroidogenic effects of ACTHar gel. Its effectiveness is a result of both its steroidogenic and direct anti-inflammatory effects through activation of different melanocortin receptors (MCRs).
Enroll in this clinical study
How is ACTHar being studied in Lupus nephritis?
ACTHar is being studied In an open-label prospective randomized study to Determine the Efficacy and Safety of Two Dosing Regimens of ACTHar in the Treatment of Proliferative Lupus Nephritis. This study will evaluate the most effective dose of ACTHar gel in proliferative LN (Class III and IV) when given with MMF, the standard of care LN therapy. The intent of this study is to determine the effectiveness and safety of ACTHar gel in an attempt to change the clinical care requirements regarding steroid use in treating LN.
Patients will be treated with CellCept 3 grams daily for 3 months, and ACTHar gel 80 U qod for the first month and ACTHar gel 80 U biw for the following 2 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
The second group will receive ACTHar biw. For all 3 months.
Eligibility Criteria
Age ≥ 16 years
Active lupus nephritis defined by Kidney biopsy documentation of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or Class IV proliferative nephritis (including Class V occurring in combination with Class III or IV) within 12 months and a urine protein/creatinine ratio >1 at time of entry to study