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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acthar Gel | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar Gel | Drug | Acthar Gel 80 U/mL solution for subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| within 56 weeks |
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Inclusion Criteria
Potential participants must meet the following summary criteria for inclusion in the study:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| AKDHC Medical Research Services, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224732 | Derived | 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. |
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Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT02633046) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
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Multiple locations enrolled participants in Argentina (3), Australia (5), Chile (4), Mexico (5), Peru (8), Turkey (13), and the United States (25).
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| ID | Title | Description |
|---|---|---|
| FG000 | Acthar Gel | All participants receive open-label treatment with Acthar Gel per protocol regimen: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2019 |
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| Tucson |
| Arizona |
| 85712 |
| United States |
| California Institute of Renal Research | Chula Vista | California | 91910 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| VERITAS Research Corp | Miami Lakes | Florida | 33014 | United States |
| Genesis Clinical Research Corp | Tampa | Florida | 33614 | United States |
| GA Nephrology | Lawrenceville | Georgia | 30046 | United States |
| NANI Research | Hinsdale | Illinois | 60521 | United States |
| University of Louisville Research Foundation, Inc. | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation, Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| NKDHC Medical Research Services, LLC | Las Vegas | Nevada | 89128 | United States |
| Icahn School of Medicine-Mt. Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Metrolina Nephrology Associates | Charlotte | North Carolina | 28204 | United States |
| Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio | 45219 | United States |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Tech University Health Science Center | Amarillo | Texas | 79106 | United States |
| Texas Kidney Institute (Neprhotex Research Group) | Dallas | Texas | 75231 | United States |
| University of Wisconsin Wisconsin Dialysis Institute | Madison | Wisconsin | 53792 | United States |
| Centro de Salud Renal JunÃn SRL | JunÃn | Buenos Aires | B6000GPB | Argentina |
| Centro de Investigaciones Médicas | Mar del Plata | Buenos Aires | B7600FYK | Argentina |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Renal Research Group | Gosford | New South Wales | 3021 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 3021 | Australia |
| Westmead Hospita | Westmead | New South Wales | 3021 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 3021 | Australia |
| Launceston Hospital | Launceston | Tasmania | 3021 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3021 | Australia |
| Sunshine Hopital - Western Health | St Albans | Victoria | 3021 | Australia |
| Hospital Dr. Hernán HenrÃquez Aravena | Temuco | Araucania | 4781151 | Chile |
| Clinica Davila | Santiago | RM | 8340518 | Chile |
| Investigación Nefrológica SC | Cuernavaca | Morelos | 64000 | Mexico |
| Hospital y ClÃnica OCA S.A de C.V | Monterrey | Nuevo León | 64000 | Mexico |
| Hospital Nacional Cayetano Heredia | San MartÃn 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 | 034360 | Turkey (Türkiye) |
| İstanbul University Faculty of Medicine | Istanbul | Topkapi | 34093 | Turkey (Türkiye) |
| Ankara NumuneTraining and Research Hospital | Ankara | 06100 | Turkey (Türkiye) |
| Ankara Training and Research Hospital | Ankara | 06340 | Turkey (Türkiye) |
| İstanbul University Faculty of Medicine | Istanbul | 34098 | Turkey (Türkiye) |
| Kocaeli University Faculty of Medicine | Kocaeli | 41380 | Turkey (Türkiye) |
| Marmara University Faculty of Medicine | Maltepe | 34840 | Turkey (Türkiye) |
| Mersin University Faculty of Medicine | Mersin | 33000 | Turkey (Türkiye) |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set, defined as all participants allocated to study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Acthar Gel | All participants receive open-label treatment with Acthar Gel per protocol regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Participants who selected multiple races or identified themselves as mixed-race are included in the Unknown category. | Count of Participants | Participants | No |
| |||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Safety population | Posted | Count of Participants | Participants | within 56 weeks |
|
|
|
within 56 weeks
Treatment emergent adverse events are recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acthar Gel | All participants receive open-label treatment with Acthar Gel per protocol regimen | 0 | 63 | 11 | 63 | 50 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-844-2830 | medinfo@mnk.com |
| Jul 14, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| 46-65 years of age |
|
| greater than 65 years of age |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Mexico |
|
| Australia |
|
| Chile |
|
| Peru |
|
| Title | Measurements |
|---|---|
|