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Keep this study
Lead
Mallinckrodt ARD LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Potential participants must meet the following summary criteria for inclusion in the study:
Is male or non-pregnant, non-lactating female
Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria response with prior therapy
Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker (or have documented intolerance), for at least 4 weeks before screening
Has blood pressure no higher than 150/90 mmHg
You may not be if
Potential participants will not be eligible for the the study if they meet the following summary criteria:
Has hepatitis B or C, tuberculosis, or other contraindication listed on the United States (US) Prescribing Information for Acthar
Has Type 1 or Type 2 diabetes mellitus or any clinically significant infection
Has received specific treatments at exclusionary time points per protocol
Has been involved in a therapeutic drug/device trial (other than for FSGS) within 4 weeks before screening
Has any other condition that might, per protocol or in the opinion of the investigator, compromise:
1. the safety and well-being of the participant or their offspring
2. the safety of study staff
3. analysis of results
Clareo Health | Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria