Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan

• Status: Active, not recruiting
• Trial end date: 2020-06-01

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.

• Phase: Phase 2

Details

• Lead Sponsor: Dimerix Bioscience Pty Ltd
• Collaborators: IQVIA; Iqvia Pty Ltd
• Treatments: Irbesartan; Proxigermanium