Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS

Overview

About this study

Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening - Men or women age 18 - 80 years at the time of screening - Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) AND endoscopic demonstration of inflammation - Stable dose of medications for Crohn's disease therapy -Prior treatment failure or intolerance with at least one Anti Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent. -Effective contraception from screening, and for 36 weeks after the last dose of investigational product -No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

Exclusion Criteria:

  • Severe underlying immunosuppression
  • Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
  • Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization,
  • Recent treatment with approved or investigational biologic therapy for Crohn's disease
  • Recent or planned live attenuated vaccine
  • History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent cure ≥ 12 months before screening
  • Pregnancy/breast feeding
  • Drug abuse

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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Additional contact information

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