TREATMENT OF PROTEINURIA DUE TO TREATMENT RESISTANT OR TREATMENT INTOLERANT IDIOPATHIC FOCAL SEGMENTAL GLOMERULOSCLEROSIS: A 2 PART PROSPECTIVE STUDY OF H.P. ACTHAR® GEL (PODOCYTE)

Mallinckrodt ARD Inc,0 个研究点目标入组 8 人开始时间: 2017年4月12日最近更新: 2023年9月4日

适应症

试验速览

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•Male or nonpregnant, nonlactating female subjects 18 years of age or older with primary FSGS (confirmed by renal biopsy) who are nephrotic (uPCR  3500 mg/g and estimated glomerular filtration rate [eGFR] ≥ 30 mL/min/1.73 m2) and who have failed to achieve sustained CR or PR of proteinuria with ≥ 1 prior immunosuppressive therapy OR intolerance ≥ 1 prior immunosuppressive therapy will be enrolled in the study. Subjects must be treated with an angiotensin converting enzyme inhibitor, an angiotensin receptor blocker, or a direct renin inhibitor (or have documentation of intolerance), for at least 4 weeks prior to Screening Visit/Visit 1 with blood pressure ≤ 150/90. For more details, refer to protocol.

•Subjects also must be negative for hepatitis B, hepatitis C, have no history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar,
•have no history of Type 1 or Type 2 diabetes, or have any clinically significant infection. Subjects cannot have taken Rituximab 24 weeks prior to Screening Visit/Visit 1, any investigational treatments for FSGS or oral corticosteroids (unless used to treat FSGS) for 12 weeks prior to Screening Visit/Visit 1, any intravenous/intramuscular corticosteroids (unless used to treat FSGS) for 8 weeks prior to Screening Visit/Visit 1, or have been involved in a therapeutic drug/device trial (other than for FSGS) 4 weeks prior to Screening Visit/Visit 1

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