Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

Phase 4

Completed

• Conditions: Idiopathic Focal Segmental Glomerulosclerosis
• Interventions: Drug: Acthar Gel

• Registration Number: NCT02633046
• Lead Sponsor: Mallinckrodt ARD LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-17
• Study Start: 2016-10-10
• Primary Completion: 2020-08-27
• Study Completion: 2020-08-27
• Results First Submitted: 2021-07-14
• Results First Submitted QC: 2021-07-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Results First Posted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acthar Gel	Acthar Gel	Acthar Gel, 1 mL (80 U) by subcutaneous injection (SC) 3x/week will be administered to all participants from Week 0 to 50. Tapering of dose to 1 mL SC 2x/week will be allowed for safety and/ tolerability issues. Once the dose is tapered to 1 mL SC 2x/week it must remain at this level. Participants unable to tolerate 1 mL SC 2x/week will be discontinued. All participants will have an End of Study/Early Termination Visit 4 weeks after discontinuing Investigational Medicinal Product (IMP).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	within 56 weeks	Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with: 1. death for any reason (all cause mortality); 2. treatment emergent serious adverse events (TESAEs); 3. any non-serious treatment emergent adverse events (TEAEs)

Trial Locations

Locations (46)

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

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