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Safety and efficacy of bleselumab when used in combination with tacrolimus for Post-renal transplant recurrent FSGS

The purpose of this study is to test if the addition of a drug called H.P. Acthar® (Repository Corticotropin Injection) to current FSGS therapy will have beneficial effects on transplanted kidney function by decreasing the amount of protein excreted through your kidney over time. Acthar is currently FDA approved for the treatment of infantile spasms in infants and children under 2 years of age and for the treatment of exacerbation of multiple sclerosis in adults, but it has not been studied specifically in transplant patients.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Extended hours (M-F, early morning or evening)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

Screening, Study Visits: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 52. 24 Hr Urine collection (3) Lab draws at each visit. Acthar injection 2x/week for weeks 1 thru 24. After the first injection you may begin receiving these injections at home when you feel comfortable.

Incentives

Contact the study team for details

In-person visits : 10
Total length of participation : 52 weeks

Looking for Specific Volunteers

Able to participate:

  • You have undergone a kidney biopsy, which resulted in your diagnosis of primary focal glomerulosclerosis (FSGS).
  • You or your partner do not plan to become pregnant for at least 15 months after transplant.

Not eligible if:

  • You will not receive a multi-organ transplant or a certain type of kidney transplant that puts you at higher risk for rejection, infection, and/or graft
  • You are not enrolled in another clinical trial in which you take an investigational drug.
  • You do not have certain conditions, including but not limited to HIV, liver disease, and/or cancer that would make it difficult for us to determine

Contact the Team

Visit Location

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

Karin True
Surgery - Transplant

Study Type

Clinical or Medical
Interventional

Study Topics

Kidneys and Liver

IRB Number

15-0999

ClinicalTrials.gov

NCT02921789

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