Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria (PODOCYTE)
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|ClinicalTrials.gov Identifier: NCT02633046|
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : August 3, 2021
Last Update Posted : August 4, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Focal Segmental Glomerulosclerosis||Drug: Acthar Gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)|
|Actual Study Start Date :||October 10, 2016|
|Actual Primary Completion Date :||August 27, 2020|
|Actual Study Completion Date :||August 27, 2020|
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
Other Name: Acthar
- 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:
- death for any reason (all cause mortality)
- treatment emergent serious adverse events (TESAEs)
- any non-serious treatment emergent adverse events (TEAEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633046
|Study Director:||Clinical Team Leader||Mallinckrodt|