Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
PODOCYTE
Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
1 other identifier
interventional
63
7 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
Longer than P75 for phase_4
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedStudy Start
First participant enrolled
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2020
CompletedResults Posted
Study results publicly available
August 3, 2021
CompletedAugust 4, 2021
August 1, 2021
3.9 years
December 15, 2015
July 14, 2021
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 1. death for any reason (all cause mortality) 2. treatment emergent serious adverse events (TESAEs) 3. any non-serious treatment emergent adverse events (TEAEs)
within 56 weeks
Study Arms (1)
Acthar Gel
OTHERActhar 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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:
- the safety and well-being of the participant or their offspring
- the safety of study staff
- analysis of results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
AKDHC Medical Research Services, LLC
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 Junín SRL
Junín, 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 Henríquez Aravena
Temuco, Región de la Araucanía, 4781151, Chile
Clinica Davila
Santiago, RM, 8340518, Chile
Investigación Nefrológica SC
Cuernavaca, Morelos, 64000, Mexico
Hospital y Clínica OCA S.A de C.V
Monterrey, Nuevo León, 64000, 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, 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)
Related Publications (1)
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.
PMID: 35224732DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 17, 2015
Study Start
October 10, 2016
Primary Completion
August 27, 2020
Study Completion
August 27, 2020
Last Updated
August 4, 2021
Results First Posted
August 3, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share
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.