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

NCT03649152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-07-29

No results posted yet for this study

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

DRUG

Propagermanium

Immediate release capsule

DRUG

Placebo

Placebo capsule

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Dimerix Bioscience Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Simon Roger, MD · Renal Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2020-06-16
Completion
2020-07-13

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649152 on ClinicalTrials.gov