Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
NCT ID: NCT02633046
Last Updated: 2021-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
63 participants
INTERVENTIONAL
2016-10-10
2020-08-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Acthar Gel
Acthar Gel 80 U/mL solution for subcutaneous injection
Interventions
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Acthar Gel
Acthar Gel 80 U/mL solution for subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion 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
18 Years
ALL
No
Sponsors
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Mallinckrodt ARD LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
Liverpool Hospital
Liverpool, New South Wales, Australia
Westmead Hospita
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Launceston Hospital
Launceston, Tasmania, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sunshine Hopital - Western Health
St Albans, Victoria, Australia
Hospital Dr. Hernán Henríquez Aravena
Temuco, Región de la Araucanía, Chile
Clinica Davila
Santiago, RM, Chile
Investigación Nefrológica SC
Cuernavaca, Morelos, Mexico
Hospital y Clínica OCA S.A de C.V
Monterrey, Nuevo León, Mexico
Hospital Nacional Cayetano Heredia
San Martín de Porres, Lima region, Peru
Hospital Nacional Alberto Sabogal
Lima, , Peru
Hospital Nacional Arzobispo Loayza
Lima, , Peru
Hospital Nacional Hospital Maria Auxiliadora
Lima Lima, , Peru
Şişli Etfal Hamidiye Training and Research Hospital
Istanbul, Sisli, Turkey (Türkiye)
İstanbul University Faculty of Medicine
Istanbul, Topkapi, Turkey (Türkiye)
Ankara NumuneTraining and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara Training and Research Hospital
Ankara, , Turkey (Türkiye)
İstanbul University Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Kocaeli University Faculty of Medicine
Kocaeli, , Turkey (Türkiye)
Marmara University Faculty of Medicine
Maltepe, , Turkey (Türkiye)
Mersin University Faculty of Medicine
Mersin, , Turkey (Türkiye)
Countries
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References
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Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MNK14224049
Identifier Type: -
Identifier Source: org_study_id
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