Back to resultsActhar for Treatment-Resistant or Treatment-Intolerant Proteinuria (PODOCYTE)
Primary Purpose
Idiopathic Focal Segmental Glomerulosclerosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Acthar Gel
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Focal Segmental Glomerulosclerosis focused on measuring FSGS, primary FSGS, idiopathic FSGS
Eligibility Criteria
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:
- the safety and well-being of the participant or their offspring
- the safety of study staff
- analysis of results
Sites / Locations
- University of Alabama at Birmingham
- AKDHC Medical Research Services, LLC
- California Institute of Renal Research
- Stanford University
- VERITAS Research Corp
- Genesis Clinical Research Corp
- GA Nephrology
- NANI Research
- University of Louisville Research Foundation, Inc.
- Ochsner Clinic Foundation, Baton Rouge
- NKDHC Medical Research Services, LLC
- Icahn School of Medicine-Mt. Sinai
- Columbia University Medical Center
- Metrolina Nephrology Associates
- Brookview Hills Research Associates, LLC
- University of Cincinnati Physicians Company, LLC
- Cincinnati VA Medical Center
- Medical University of South Carolina
- Texas Tech University Health Science Center
- Texas Kidney Institute (Neprhotex Research Group)
- University of Wisconsin Wisconsin Dialysis Institute
- Centro de Salud Renal Junín SRL
- Centro de Investigaciones Médicas
- Sanatorio Allende
- Renal Research Group
- Liverpool Hospital
- Westmead Hospita
- Royal Brisbane and Women's Hospital
- Launceston Hospital
- The Alfred Hospital
- Sunshine Hopital - Western Health
- Hospital Dr. Hernán Henríquez Aravena
- Clinica Davila
- Investigación Nefrológica SC
- Hospital y Clínica OCA S.A de C.V
- Hospital Nacional Cayetano Heredia
- Hospital Nacional Hospital Maria Auxiliadora
- Hospital Nacional Alberto Sabogal
- Hospital Nacional Arzobispo Loayza
- Şişli Etfal Hamidiye Training and Research Hospital
- İstanbul University Faculty of Medicine
- Ankara NumuneTraining and Research Hospital
- Ankara Training and Research Hospital
- İstanbul University Faculty of Medicine
- Kocaeli University Faculty of Medicine
- Marmara University Faculty of Medicine
- Mersin University Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Acthar Gel
Arm Description
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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02633046
Brief Title
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
Acronym
PODOCYTE
Official Title
Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt ARD LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Focal Segmental Glomerulosclerosis
Keywords
FSGS, primary FSGS, idiopathic FSGS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acthar Gel
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Acthar Gel
Other Intervention Name(s)
Acthar
Intervention Description
Acthar Gel 80 U/mL solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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)
Time Frame
within 56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
the safety and well-being of the participant or their offspring
the safety of study staff
analysis of results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
AKDHC Medical Research Services, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
VERITAS Research Corp
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Genesis Clinical Research Corp
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
GA Nephrology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
NANI Research
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
University of Louisville Research Foundation, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation, Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
NKDHC Medical Research Services, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Icahn School of Medicine-Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Metrolina Nephrology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Brookview Hills Research Associates, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati Physicians Company, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Tech University Health Science Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Kidney Institute (Neprhotex Research Group)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Wisconsin Wisconsin Dialysis Institute
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Centro de Salud Renal Junín SRL
City
Junín
State/Province
BA
ZIP/Postal Code
B6000GPB
Country
Argentina
Facility Name
Centro de Investigaciones Médicas
City
Mar del Plata
State/Province
BA
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Sanatorio Allende
City
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Renal Research Group
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
3021
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
3021
Country
Australia
Facility Name
Westmead Hospita
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
3021
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
3021
Country
Australia
Facility Name
Launceston Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
3021
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Sunshine Hopital - Western Health
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Hospital Dr. Hernán Henríquez Aravena
City
Temuco
State/Province
IX Region
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Clinica Davila
City
Santiago
State/Province
RM
ZIP/Postal Code
8340518
Country
Chile
Facility Name
Investigación Nefrológica SC
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital y Clínica OCA S.A de C.V
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital Nacional Cayetano Heredia
City
San Martin de Porres
State/Province
Lima
Country
Peru
Facility Name
Hospital Nacional Hospital Maria Auxiliadora
City
Lima Lima
Country
Peru
Facility Name
Hospital Nacional Alberto Sabogal
City
Lima
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
Country
Peru
Facility Name
Şişli Etfal Hamidiye Training and Research Hospital
City
İstanbul
State/Province
Sisli
ZIP/Postal Code
034360
Country
Turkey
Facility Name
İstanbul University Faculty of Medicine
City
İstanbul
State/Province
Topkapi
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ankara NumuneTraining and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Training and Research Hospital
City
Ankara
ZIP/Postal Code
06340
Country
Turkey
Facility Name
İstanbul University Faculty of Medicine
City
İstanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Kocaeli University Faculty of Medicine
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Marmara University Faculty of Medicine
City
Maltepe
ZIP/Postal Code
34840
Country
Turkey
Facility Name
Mersin University Faculty of Medicine
City
Mersin
ZIP/Postal Code
33000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
35224732
Citation
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.
Results Reference
derived
Learn more about this trial
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
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