Idiopathic Focal Segmental GlomerulosclerosisPhase 4PODOCYTENCT02633046
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
A Phase 4 study testing Acthar Gel in people with Idiopathic Focal Segmental Glomerulosclerosis, run by Mallinckrodt ARD LLC at 47 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Focal Segmental Glomerulosclerosis
- What is being tested?
- Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 47 sitesin 7 countries
- Study dates
- 10 Oct 2016to 27 Aug 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United States21 sites
Texas Tech University Health Science Center
Amarillo, Texas, 79106
Ochsner Clinic Foundation, Baton Rouge
Baton Rouge, Louisiana, 70809
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
Metrolina Nephrology Associates
Charlotte, North Carolina, 28204
California Institute of Renal Research
Chula Vista, California, 91910
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, 45219
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Texas Kidney Institute (Neprhotex Research Group)
Dallas, Texas, 75231
NANI Research
Hinsdale, Illinois, 60521
NKDHC Medical Research Services, LLC
Las Vegas, Nevada, 89128
GA Nephrology
Lawrenceville, Georgia, 30046
University of Louisville Research Foundation, Inc.
Louisville, Kentucky, 40202
University of Wisconsin Wisconsin Dialysis Institute
Madison, Wisconsin, 53792
VERITAS Research Corp
Miami Lakes, Florida, 33014
Icahn School of Medicine-Mt. Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Stanford University
Stanford, California, 94305
Genesis Clinical Research Corp
Tampa, Florida, 33614
AKDHC Medical Research Services, LLC
Tucson, Arizona, 85712
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103
Turkey (Türkiye)8 sites
Ankara NumuneTraining and Research Hospital
Ankara, 06100
Ankara Training and Research Hospital
Ankara, 06340
Şişli Etfal Hamidiye Training and Research Hospital
Istanbul, Sisli, 034360
İstanbul University Faculty of Medicine
Istanbul, Topkapi, 34093
İstanbul University Faculty of Medicine
Istanbul, 34098
Kocaeli University Faculty of Medicine
Kocaeli, 41380
Marmara University Faculty of Medicine
Maltepe, 34840
Mersin University Faculty of Medicine
Mersin, 33000
Australia7 sites
Renal Research Group
Gosford, New South Wales, 3021
Royal Brisbane and Women's Hospital
Herston, Queensland, 3021
Launceston Hospital
Launceston, Tasmania, 3021
Liverpool Hospital
Liverpool, New South Wales, 3021
The Alfred Hospital
Melbourne, Victoria, 3021
Sunshine Hopital - Western Health
St Albans, Victoria, 3021
Westmead Hospita
Westmead, New South Wales, 3021
Peru4 sites
Hospital Nacional Alberto Sabogal
Lima
Hospital Nacional Arzobispo Loayza
Lima
Hospital Nacional Hospital Maria Auxiliadora
Lima Lima
Hospital Nacional Cayetano Heredia
San Martín de Porres, Lima region
Argentina3 sites
Sanatorio Allende
Córdoba, X5000JHQ
Centro de Salud Renal Junín SRL
Junín, Buenos Aires, B6000GPB
Centro de Investigaciones Médicas
Mar del Plata, Buenos Aires, B7600FYK
Chile2 sites
Clinica Davila
Santiago, RM, 8340518
Hospital Dr. Hernán Henríquez Aravena
Temuco, Araucania, 4781151
Mexico2 sites
Investigación Nefrológica SC
Cuernavaca, Morelos, 64000
Hospital y Clínica OCA S.A de C.V
Monterrey, Nuevo León, 64000
About this study
Official title: Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
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.
Read more
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.
- Being tested
- Acthar Gel
- Keywords
- FSGS, primary FSGS, idiopathic FSGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar GelDrug
Also called Acthar
Acthar Gel 80 U/mL solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Acthar Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start10 Oct 2016
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt ARD LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633046
- Sponsor's protocol ID
- MNK14224049
- Acronym
- PODOCYTE
- Status last verified
- Aug 2021
- First submitted
- 15 Dec 2015
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35224732
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
- ClinicalTrials.gov ID
- NCT02633046
- Acronym / sponsor ID
- PODOCYTE / MNK14224049
- Keywords
- FSGS, primary FSGS, idiopathic FSGS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mallinckrodt ARD LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 3 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acthar Gel | Other | Drug: Acthar GelActhar 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar GelAlso: ActharActhar Gel 80 U/mL solution for subcutaneous injection | Drug | Acthar Gel |
Primary outcome
Number of Participants With Adverse Events
Time frame: within 56 weeks
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35224732Hodson 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team Leader study director
Mallinckrodt
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acthar Gel in people with Idiopathic Focal Segmental Glomerulosclerosis, run by Mallinckrodt ARD LLC at 47 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Turkey (Türkiye), Australia, Peru, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: within 56 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.