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Clinical Trial Summary

This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS.

The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized to ensure 26 subjects complete the study. An optional 9 month open label is available


Clinical Trial Description

This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS.

The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized.

Study participation for each subject will last up to 5 months. The study will consist of a screening period not to exceed 30 days (1 month), 90-day (3 month) treatment period, and an approximate 28-day (1 month) follow-up period after the last dose of study medication. An optional 9 month open label is available. ;


Study Design


Related Conditions & MeSH terms

  • Glomerulosclerosis, Focal Segmental
  • Primary Focal Segmental Glomerulosclerosis

NCT number NCT03422510
Study type Interventional
Source Complexa, Inc.
Contact
Status Completed
Phase Phase 2
Start date April 15, 2018
Completion date July 31, 2020

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