An Open-Label Phase 2 Proof or Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471

  • STATUS
    Recruiting
  • participants needed
    2
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Updated on 19 February 2024

Summary

This is an open-label study of 12 months of dosing with ACH-0144471. The study will enroll patients with biopsy-confirmed C3G or IC-MPGN who meet eligibility criteria for this study. There will be a multi-step screening process. At the initial screening visit, all screening eligibility assessments, except the renal biopsy, will be performed. If the subject remains eligible based on the results from the initial screening visit, then arrangements can be made for renal biopsy and vaccinations. The initial screening visit must occur no more than 75 days before the first dose date. The renal biopsy must occur no more than 30 days before the first dose, but will be targeted to occur approximately two weeks prior to the first dose of ACH-0144471.

Description


FAQ

For any questions related to the study, please contact the study coordinators below:
Stacey Lau - Stacey.lau@uphs.upenn.edu; (215)220-9544
Krishna Kallem - Krishna.kallem@uphs.upenn.edu; (484)358-0315

Details
Condition C3,IC-MPGN
Age 17years - 65years
Clinical Study Identifier03459443
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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