This study is testing three new treatments for people who have Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD).
FSGS or MCD are kidney conditions that cause protein to leak into the urine. This study aims to find out if these new medicines are safe and whether they help reduce protein in the urine and improve symptoms. Participants will receive one of the three study medicines or a placebo, with most receiving active treatment. Study visits include blood and urine tests, questionnaires, and check-ups over about 18 months.
Anticipated enrolment close date: 11 February 2028
Who can take part
You may be able to take part in this study at RMH if you:
- Are aged between 18 and 75 years - the study is open to people aged 16 and 17 years of age, however the RMH only has approval to recruit people aged 18 and over
- Have been diagnosed with Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
- Are not pregnant or breastfeeding
- Are willing to use effective contraception during the study (if applicable)
- Are not currently taking high-dose steroids or other strong immune-suppressing medicines
- Are generally healthy enough to attend study visits and complete study requirement
You cannot take part if you:
- Have infections such as hepatitis B, hepatitis C, HIV, or active tuberculosis
- Have another major illness or a condition that the study doctor thinks could affect your safety or the results of the study
What's involved
Participants in this study will be asked to:
- Attend regular hospital visits over about 18 months
- Have blood and urine samples collected at multiple visits
- Complete health checks including blood pressure, weight, ECGs, and physical exams
- Answer regular questionnaires about symptoms and quality of life
- Receive study treatment by injection, tablet, or drip depending on the group they are in
- Possibly take part in an interview about their experience in the study
Some participants may also be asked to:
- Provide extra blood or urine samples for optional genetic and biomarker testing
- Use a diary or handheld device to record daily symptoms and medication use
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.