The PODOCYTE Study
Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS (PODOCYTE)
This study will examine the effectiveness of Acthar® Gel in adults subjects with FSGS who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.
Trial for people with
Primary focal segmental glomerulosclerosis (FSGS)
The purpose of the study is to determine whether H.P. Acthar® Gel (repository corticotropin injection) is helpful for adult patients with FSGS who still have an abnormal amount of protein in their urine, despite prior treatment.
What is involved for the Patient?
If you are enrolled in the study, you will receive Acthar three times a week for 24 weeks as tolerated. After 24 weeks, you will take the study drug twice a week for two weeks. At the end of those two weeks, the study doctor will decide what happens next based on how well your kidneys work after taking the study drug.
About the drug or intervention
Acthar contains the hormone ACTH, which stands for adrenocorticotropin. Acthar is a gel when refrigerated; at room temperature, it changes to liquid form, ready for injection.
- Study CoordinatorClinical Trial Team
- Study Coordinator Emailclinicaltrials@mnk.com
- Study Coordinator Phone800-556-3314
- Site NameHospital Nacional Arzobispo Loayza
- SponsorMallinckrodt Pharmaceuticals
- Study DrugActhar
- Estimated enrollment236
- Estimated end dateJune, 2021