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)

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

NKDHC Medical Research Services, LLC; 🇺🇸 Las Vegas, Nevada, United States

University of Cincinnati Physicians Company, LLC; 🇺🇸 Cincinnati, Ohio, United States

Centro de Salud Renal Junín SRL; 🇦🇷 Junín, BA, Argentina

Launceston Hospital; 🇦🇺 Launceston, Tasmania, Australia

Hospital Dr. Hernán Henríquez Aravena; 🇨🇱 Temuco, IX Region, Chile

Investigación Nefrológica SC; 🇲🇽 Cuernavaca, Morelos, Mexico

Hospital Nacional Cayetano Heredia; 🇵🇪 San Martin de Porres, Lima, Peru

Şişli Etfal Hamidiye Training and Research Hospital; 🇹🇷 İstanbul, Sisli, Turkey

Hospital Nacional Hospital Maria Auxiliadora; 🇵🇪 Lima Lima, Peru

Ankara Training and Research Hospital; 🇹🇷 Ankara, Turkey

Kocaeli University Faculty of Medicine; 🇹🇷 Kocaeli, Turkey

Marmara University Faculty of Medicine; 🇹🇷 Maltepe, Turkey

VERITAS Research Corp; 🇺🇸 Miami Lakes, Florida, United States

AKDHC Medical Research Services, LLC; 🇺🇸 Tucson, Arizona, United States

Renal Research Group; 🇦🇺 Gosford, New South Wales, Australia

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Metrolina Nephrology Associates; 🇺🇸 Charlotte, North Carolina, United States

Cincinnati VA Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Hospital Nacional Alberto Sabogal; 🇵🇪 Lima, Peru

Westmead Hospita; 🇦🇺 Westmead, New South Wales, Australia

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia

California Institute of Renal Research; 🇺🇸 Chula Vista, California, United States

University of Wisconsin Wisconsin Dialysis Institute; 🇺🇸 Madison, Wisconsin, United States

Stanford University; 🇺🇸 Stanford, California, United States

GA Nephrology; 🇺🇸 Lawrenceville, Georgia, United States

Genesis Clinical Research Corp; 🇺🇸 Tampa, Florida, United States

Icahn School of Medicine-Mt. Sinai; 🇺🇸 New York, New York, United States

University of Louisville Research Foundation, Inc.; 🇺🇸 Louisville, Kentucky, United States

NANI Research; 🇺🇸 Hinsdale, Illinois, United States

Texas Tech University Health Science Center; 🇺🇸 Amarillo, Texas, United States

Texas Kidney Institute (Neprhotex Research Group); 🇺🇸 Dallas, Texas, United States

Clinica Davila; 🇨🇱 Santiago, RM, Chile

İstanbul University Faculty of Medicine; 🇹🇷 İstanbul, Turkey

Ochsner Clinic Foundation, Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Centro de Investigaciones Médicas; 🇦🇷 Mar del Plata, BA, Argentina

Sanatorio Allende; 🇦🇷 Córdoba, Argentina

Sunshine Hopital - Western Health; 🇦🇺 St Albans, Victoria, Australia

Hospital y Clínica OCA S.A de C.V; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Hospital Nacional Arzobispo Loayza; 🇵🇪 Lima, Peru

Ankara NumuneTraining and Research Hospital; 🇹🇷 Ankara, Turkey

Mersin University Faculty of Medicine; 🇹🇷 Mersin, Turkey

Brookview Hills Research Associates, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States