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)

Not Applicable

• Conditions: -N001 Acute nephritic syndrome, focal and segmental glomerular lesions; Acute nephritic syndrome, focal and segmental glomerular lesions; N001

• Registration Number: PER-042-16
• Lead Sponsor: Mallinckrodt ARD Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-12
• Study Completion: 2020-08-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified