A Phase 4 interventional study of Acthar Gel in Idiopathic Focal Segmental Glomerulosclerosis, sponsored by Mallinckrodt ARD LLC. Completed at 47 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by Mallinckrodt ARD LLC (part of Keenova Therapeutics plc) · Phase 4, Interventional, and Treatment
Among 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States — 17 open to participants now, 20 under way, 2 of them phase 3. Glomerulosclerosis, Focal Segmental · United States.
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, this one is the 14th largest by enrollment of the 56 interventional ones, is one of 2 that started in 2016, is one of 4 in phase 4, and was the 30th registered.
105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.
This study's enrollment of 63 is above the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.
Browse Glomerulosclerosis, Focal Segmental studies →17 of the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 30 Glomerulosclerosis, Focal Segmental studies recruiting now, 11 (37%) set no upper age limit and 12 (40%) stop at 75 or younger; 22 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →68 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 2 started in 2016.
Median enrollment 30 across the 56 interventional studies, 201 across the 12 observational. Of the 45 that completed or were terminated, 23 (51%) have results posted.
33 of 68 have an industry lead sponsor. The 10 most frequent:
Mallinckrodt ARD LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Mallinckrodt ARD LLC has 1 study filed under Glomerulosclerosis, Focal Segmental — fewer than ten, so there is no comparison to draw.
10 of the studies in Glomerulosclerosis, Focal Segmental with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01094327University of MiamiProteinuria in Pre and Post Transplant | 2026-11-30 |
| NCT06500702SanofiA Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease | 2026-12-23 |
| NCT07219121Travere Therapeutics, Inc.Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis | 2027-03 |
| NCT05583942Northwell HealthA Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS) | 2027-03-01 |
| NCT05588063Northwell HealthtaVNS for FRNS in Children | 2027-03-01 |
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 any other condition that might, per protocol or in the opinion of the investigator, compromise:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Acthar Gel
Acthar Gel 80 U/mL solution for subcutaneous injection
Also known as: Acthar
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)
Time frame: within 56 weeks
Multiple locations enrolled participants in Argentina (3), Australia (5), Chile (4), Mexico (5), Peru (8), Turkey (13), and the United States (25).
| Milestone | Acthar Gel |
|---|---|
| Started | 63 |
| Safety population | 63 |
| Completed | 36 |
| Not completed | 27 |
| Withdrew: Adverse event | 8 |
| Withdrew: Physician decision | 7 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Increased proteinuria | 2 |
| Withdrew: Participant decided not to continue with open label extension | 1 |
| Withdrew: Mutual decision patient and physician | 1 |
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)
| Participants | Acthar Gel |
|---|---|
| Deaths | 0 |
| Serious TEAEs | 11 |
| Non-serious TEAEs | 60 |
Collected over within 56 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acthar Gel | 0/63 (0%) | 11/63 (17.5%) | 50/63 (79.4%) |
| Event | Acthar Gel |
|---|---|
| Acute myocardial infarctionCardiac disorders | 2/63 |
| OedemaGeneral disorders | 1/63 |
| PyrexiaGeneral disorders | 1/63 |
| GastroenteritisInfections and infestations | 1/63 |
| Soft tissue infectionInfections and infestations | 1/63 |
| Blood creatinine increasedInvestigations | 1/63 |
| HypokalaemiaMetabolism and nutrition disorders | 1/63 |
| Acute psychosisPsychiatric disorders | 1/63 |
| Stasis dermatitisSkin and subcutaneous tissue disorders | 1/63 |
| Hypertensive urgencyVascular disorders | 1/63 |
| Event | Acthar Gel |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 14/63 |
| OedemaGeneral disorders | 10/63 |
| HypokalaemiaMetabolism and nutrition disorders | 10/63 |
| HypertensionVascular disorders | 10/63 |
| InsomniaPsychiatric disorders | 9/63 |
| DiarrhoeaGastrointestinal disorders | 6/63 |
| HeadacheNervous system disorders | 6/63 |
| ConstipationGastrointestinal disorders | 5/63 |
| NauseaGastrointestinal disorders | 5/63 |
| FatigueGeneral disorders | 5/63 |
Safety analysis set, defined as all participants allocated to study treatment
| Age, Continuous(years) | Acthar Gel |
|---|---|
| Mean | 36.1 ± 13.54 |
| Age, Customized(Participants) | Acthar Gel |
|---|---|
| 18-25 years of age | 16 |
| 26-45 years of age | 29 |
| 46-65 years of age | 17 |
| greater than 65 years of age | 1 |
| Sex: Female, Male(Participants) | Acthar Gel |
|---|---|
| Female | 29 |
| Male | 34 |
| Race (NIH/OMB)(Participants) | Acthar Gel |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 8 |
| Region of Enrollment(participants) | Acthar Gel |
|---|---|
| Argentina | 3 |
| Turkey | 13 |
| United States | 25 |
| Mexico | 5 |
| Australia | 5 |
| Chile | 4 |
| Peru | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Ran from Oct 2016 to primary completion in Aug 2020, 46 months.
Results were first posted in Aug 2021, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Glomerulosclerosis, Focal Segmental →