Idiopathic Focal Segmental Glomerulosclerosis Clinical Trial
— PODOCYTEOfficial title:
Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
| Verified date | August 2021 |
| Source | Mallinckrodt |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 63 |
| Est. completion date | August 27, 2020 |
| Est. primary completion date | August 27, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria 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 Exclusion Criteria 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: 1. the safety and well-being of the participant or their offspring 2. the safety of study staff 3. analysis of results |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Sanatorio Allende | Córdoba | |
| Argentina | Centro de Salud Renal Junín SRL | Junín | BA |
| Argentina | Centro de Investigaciones Médicas | Mar del Plata | BA |
| Australia | Renal Research Group | Gosford | New South Wales |
| Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
| Australia | Launceston Hospital | Launceston | Tasmania |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Sunshine Hopital - Western Health | St Albans | Victoria |
| Australia | Westmead Hospita | Westmead | New South Wales |
| Chile | Clinica Davila | Santiago | RM |
| Chile | Hospital Dr. Hernán Henríquez Aravena | Temuco | IX Region |
| Mexico | Investigación Nefrológica SC | Cuernavaca | Morelos |
| Mexico | Hospital y Clínica OCA S.A de C.V | Monterrey | Nuevo Leon |
| Peru | Hospital Nacional Alberto Sabogal | Lima | |
| Peru | Hospital Nacional Arzobispo Loayza | Lima | |
| Peru | Hospital Nacional Hospital Maria Auxiliadora | Lima Lima | |
| Peru | Hospital Nacional Cayetano Heredia | San Martin de Porres | Lima |
| Turkey | Ankara NumuneTraining and Research Hospital | Ankara | |
| Turkey | Ankara Training and Research Hospital | Ankara | |
| Turkey | Istanbul University Faculty of Medicine | Istanbul | |
| Turkey | Istanbul University Faculty of Medicine | Istanbul | Topkapi |
| Turkey | Sisli Etfal Hamidiye Training and Research Hospital | Istanbul | Sisli |
| Turkey | Kocaeli University Faculty of Medicine | Kocaeli | |
| Turkey | Marmara University Faculty of Medicine | Maltepe | |
| Turkey | Mersin University Faculty of Medicine | Mersin | |
| United States | Texas Tech University Health Science Center | Amarillo | Texas |
| United States | Ochsner Clinic Foundation, Baton Rouge | Baton Rouge | Louisiana |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Metrolina Nephrology Associates | Charlotte | North Carolina |
| United States | California Institute of Renal Research | Chula Vista | California |
| United States | Cincinnati VA Medical Center | Cincinnati | Ohio |
| United States | University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio |
| United States | Texas Kidney Institute (Neprhotex Research Group) | Dallas | Texas |
| United States | NANI Research | Hinsdale | Illinois |
| United States | NKDHC Medical Research Services, LLC | Las Vegas | Nevada |
| United States | GA Nephrology | Lawrenceville | Georgia |
| United States | University of Louisville Research Foundation, Inc. | Louisville | Kentucky |
| United States | University of Wisconsin Wisconsin Dialysis Institute | Madison | Wisconsin |
| United States | VERITAS Research Corp | Miami Lakes | Florida |
| United States | Columbia University Medical Center | New York | New York |
| United States | Icahn School of Medicine-Mt. Sinai | New York | New York |
| United States | Stanford University | Stanford | California |
| United States | Genesis Clinical Research Corp | Tampa | Florida |
| United States | AKDHC Medical Research Services, LLC | Tucson | Arizona |
| United States | Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Mallinckrodt ARD LLC |
United States, Argentina, Australia, Chile, Mexico, Peru, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with:
death for any reason (all cause mortality) treatment emergent serious adverse events (TESAEs) any non-serious treatment emergent adverse events (TEAEs) |
within 56 weeks |