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.
Who may qualify.
You must meet the following criteria, in addition to other criteria, to qualify:
- Male or female 18 years of age or older
- Have a history of primary FSGS confirmed by a renal biopsy within the prior three years or, if the biopsy is more than three years ago, be willing to have another renal biopsy as part of the study
- Willing and able to comply with the study instructions
After you give consent to participate in this research study, you will have an initial screening visit to determine if you are eligible for the PODOCYTE Study. The approximate duration of participation is up to 65 weeks.
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. The potential options are listed below.
- Randomized maintenance period: Patients who respond to treatment with the study drug over 24 weeks will be assigned to this group. If assigned to this group, participants will inject the study drug or placebo two times a week for 24 additional weeks with monthly clinic visits.
- Open-label extension period: Patients who do not respond to treatment with the study drug will have the choice of continuing the study drug either two times a week or three times a week (depending on Visit 8 dosage) for an additional 24 weeks.
During your monthly site visits with the study doctor, you will undergo blood work, clinical and physical examinations, and a review of how you are feeling.
See If You May Qualify