ACTHar in the Treatment of Lupus Nephritis (NCT02226341) | Clinical Trial Compass
TerminatedPhase 4
ACTHar in the Treatment of Lupus Nephritis
Stopped: Lack of funding
United States8 participantsStarted 2014-10
Plain-language summary
Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and safety of two dosing arms of ACTHar gel in treating proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar are safe and effective in treating proliferative LN (Class III and IV).
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR)/SLICC criteria
✓. Age ≥ 16 years
✓. Active lupus nephritis defined by:
✓. Ability to provide informed consent
Exclusion criteria
✕. Moderately severe anemia (Hgb \< 8 mg/dL)
✕. Neutropenia (\< 1,000/mm3)
✕. Thrombocytopenia (platelets \< 50,000/mm3)
✕. Positive purified protein derivative (PPD) test confirmed by positive Quantiferon TB gold.
✕. Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis
✕. Active infections that in the opinion of the investigator increase the risks to the subject.