The PODOCYTE Study

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS (The PODOCYTE Study)

The purpose of the study is to determine whether H.P. Acthar® Gel (repository corticotropin injection) is helpful for adult patients with FSGS who still have an abnormal amount of protein in their urine, despite prior treatment.

You must meet the following criteria, in addition to other criteria, to qualify:

• Male or female 18 years of age or older
• Have a history of primary FSGS confirmed by a renal biopsy within the prior three years or, if the biopsy is more than three years ago, be willing to have another renal biopsy as part of the study
• Willing and able to comply with the study instructions

After you give consent to participate in this research study, you will have an initial screening visit to determine if you are eligible for the PODOCYTE Study. The approximate duration of participation is up to 65 weeks.

If you are enrolled in the study, you will receive Acthar three times a week for 24 weeks as tolerated. After 24 weeks, you will take the study drug twice a week for two weeks. At the end of those two weeks, the study doctor will decide what happens next based on how well your kidneys work after taking the study drug.

Contact a study center:

• Click here to visit the study website

 

Clinical Trial Locations – United States

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City	State	Site Location
Birmingham	Alabama	University of Birmingham
Glendale	Arizona	AKDHC Medical Research Services
Tempe	Arizona	Mallinckrodt Investigational Site
Tuscon	Arizona	AKDHC Medical Research Services
Chula Vista	California	California Institute of Renal Research
Glendale	California	Kidney Disease Medical Group, INC.
Los Angeles	California	Academic Medical Research Institute
Stanford	California	Stanford University
Washington	District of Columbia	Georgetown University Medical Center
Miami Lakes	Florida	VERITAS Research Corp
Miami Springs	Florida	Ocean Blue Medical Research
Orlando	Florida	Orlando VA Medical Center
Tampa	Florida	Genesis Clinical Research Corp
Augusta	Georgia	Georgia Regents University
Lawrenceville	Georgia	GA Nephrology
Hinsdale	Illinois	NANI Research
Louisville	Kentucky	University of Louisville Research Foundation, INC.
Baton Rouge	Louisiana	Ochsner Clinic Foundation
New Orleans	Louisiana	Ochsner Clinic Foundation
Schreveport	Louisiana	Mallinckrodt Investigational Site
Takoma Park	Maryland	Washington Nephrology Associates
Rochester	Minnesota	Mayo Clinic - Rochester
St. Louis	Missouri	Mallinckrodt Investigational Site
Las Vegas	Nevada	NKDHC Medical Research Services, LLC
Albany	New York	AMC Nephrology Group
Laurelton	New York	Scott Research INC.
New York	New York	Icahn School of Medicine - Mt. Sinai
New York	New York	Columbia University Medical Center
Charlotte	North Carolina	Metrolina Nephrology Associates
Greenville	North Carolina	Eastern Nephrology Associates
Winston-Salem	North Carolina	Brookview Hills Research Associates, LLC
Cincinnati	Ohio	University of Cincinnati Physicians Company, LLC.
Cincinnati	Ohio	Cincinnati VA Medical Center
Cleveland	Ohio	The Cleveland Clinic Foundation
Columbus	Ohio	Ohio State University
Philadelphia	Pennsylvania	University of Pennsylvania
Charleston	South Carolina	Medical University of South Carolina
Knoxville	Tennessee	Knoxvilla Kidney Center
Amarillo	Texas	Texas Tech University Health Science Center
Dallas	Texas	Texas Kidney Institute - Nephrotex Research Group
Temple	Texas	Baylor Scott and White
Alexandria	Virginia	Washington Nephrology Associates
Arlington	Virginia	Virginia Nephrology Group - IntegraTrials LLC.
Madison	Wisconsin	University of Wisconsin, Wisconsin Dialysis Institute

Clinical Trial Locations – International

City	State, Country	Study Location
Junin	BA, Argentina	Centra de Salud Renal Junio SRL
Mar Del Plataa	BA, Argentina	Centro de Investigaciones Medicas
Temperley	BA, Argentina	Centro de Hemodialisis Temperley
Cordoba	Argentina	Sanatario Allende
Cordoba	Argentina	Instituto Privado de Especialidades Medicas
Gosford	New South Wales, Australia	Renal Research Group
Liverpool	New South Wales, Australia	Liverpool Hospital
Westmead	New South Wales, Australia	Westmead Hospital
Herston	Queensland, Australia	Royal Brisbane and Women's Hospital
Launceston	Taasmania, Australia	Launceston Hospital
Melbourne	Victoria, Australia	The Alfred Hospital
St. Albans	Victoria, Australia	Sunshine Hospital - Western Health
Vancouver	British Columbia, Canada	St. Paul's Hospital
Temuco	IX Region, Chile	Hospital Dr. Herman Henriquez Aravena
Santiago	RM, Chile	Hospital del Salvador
Santiago	RM, Chile	Clinica Davilla
Santiago	RM, Chile	Hospital Clinic de la Universidad de Chile
Hong Kong	Hong Kong, China	Pamela You Nethersole Eastern Hospital
Hong Kong	Hong Kong, China	Princess Margaret Hospital
Hong Kong	Hong Kong, China	University of Hong Kong, Queen Mary Hospital
Hong Kong	Hong Kong, China	Tuen Mun Hospital
Cuernavaca	Morelos, Mexico	Investigacion Nefrologica SC
Monterrey	Nuevo Leon, Mexico	Hospital y Clinica OCA S.A. de C.V.
Auckland	New Zealand	Auckland City Hospital
Hamilton	New Zealand	Waikato Hospital
San Martin de Porres	Lima, Peru	Hospital Nacional Cayetano Heredia
Lima	Peru	Hospital Nacional Arzobispo Loayza
San Juan	Puerto Rico	Pavia Research Center/Nefrologica Asociaccion de Santurce
Istanbul	Sisli, Turkey	Sisli Etfal Hamidiye Training and Research
Istanbul	Topkapi, Turkey	Istanbul University Faculty of Medicine
Adana	Turkey	Cukurova University Faculty of MEdicine
Ankara	Turkey	Ankara Training and Research Hospital
Ankara	Turkey	Ankara Numune Training and Research Hospital
Istanbul	Turkey	Istanbul University Faculty of Medicine
Kocaeli	Turkey	Kocaeli University Faculty of Medicine
Maltepe	Turkey	Marmara University Faculty of Medicine
Mersin	Turkey	Mersin University Faculty of Medicine

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