NCT03649152

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

A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dimerix Bioscience Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Segmental Glomerulosclerosis

Interventions

Type	Name	Description
DRUG	Propagermanium	Immediate release capsule
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2018-11-08
• Primary completion: 2020-06-16
• Completion: 2020-07-13
• First posted: 2018-08-28
• Last updated: 2022-07-29

Locations

11 sites across 1 country: Australia