Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

Completed · Phase 4

Conditions studied: Idiopathic Focal Segmental Glomerulosclerosis

In brief

Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters" let protein get into the kidney. FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney failure is dialysis or kidney transplant. Proteinuria means too much protein came through the kidneys into the urine. If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS. This kind of FSGS is very hard to treat. This study will test Acthar in patients with this condition who have not responded to other treatments. It primarily investigates how well the therapy is tolerated by the patients and how well they respond to this treatment.

Key facts

Study ID

NCT02633046

Run by

Mallinckrodt ARD LLC

People needed

63

Starts

2016-10-10

Expected to finish

2020-08-27

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• Meets all other inclusion criteria detailed in the protocol

You may not qualify 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
• Meets any other exclusion criteria detailed in the protocol
• Has any other condition that might, per protocol or in the opinion of the investigator, compromise:
• the safety and well-being of the participant or their offspring
• the safety of study staff
• analysis of results

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• AKDHC Medical Research Services, LLC — Tucson, Arizona, United States
• California Institute of Renal Research — Chula Vista, California, United States
• Stanford University — Stanford, California, United States
• VERITAS Research Corp — Miami Lakes, Florida, United States
• Genesis Clinical Research Corp — Tampa, Florida, United States
• GA Nephrology — Lawrenceville, Georgia, United States
• NANI Research — Hinsdale, Illinois, United States
• University of Louisville Research Foundation, Inc. — Louisville, Kentucky, United States
• Ochsner Clinic Foundation, Baton Rouge — Baton Rouge, Louisiana, United States
• NKDHC Medical Research Services, LLC — Las Vegas, Nevada, United States
• Icahn School of Medicine-Mt. Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Metrolina Nephrology Associates — Charlotte, North Carolina, United States
• Brookview Hills Research Associates, LLC — Winston-Salem, North Carolina, United States
• University of Cincinnati Physicians Company, LLC — Cincinnati, Ohio, United States
• Cincinnati VA Medical Center — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Tech University Health Science Center — Amarillo, Texas, United States
• Texas Kidney Institute (Neprhotex Research Group) — Dallas, Texas, United States
• University of Wisconsin Wisconsin Dialysis Institute — Madison, Wisconsin, United States
• Centro de Salud Renal Junín SRL — Junín, Buenos Aires, Argentina
• Centro de Investigaciones Médicas — Mar del Plata, Buenos Aires, Argentina
• Sanatorio Allende — Córdoba, Argentina
• Renal Research Group — Gosford, New South Wales, Australia

Full record on ClinicalTrials.gov

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