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Clinical Trial Summary

This study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with FSGS who are already taking irbesartan by: - monitoring symptoms that participants may experience while on the study, - measuring levels of protein in participant's urine and kidney function during the course of the study, - measuring the levels of propagermanium and irbesartan that enters into participant's urine and blood, and - comparing the propagermanium outcomes to participants' pre-study and placebo outcomes. Eligible participants will randomly be assigned to one of two arms to receive both the propagermanium and placebo in different orders as follows, either: Treatment Period 1 taking a propagermanium capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day for 16 weeks. OR Treatment Period 1 taking a placebo capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a day for 16 weeks.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Focal Segmental Glomerulosclerosis
  • Glomerulosclerosis, Focal Segmental

NCT number NCT03649152
Study type Interventional
Source Dimerix Bioscience Pty Ltd
Contact
Status Completed
Phase Phase 2
Start date November 8, 2018
Completion date July 13, 2020

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