Phase 3 Chronic Kidney Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be between 1 and 18 years old at the time of signing the consent form
- You must have previously taken part in the FIONA clinical trial (study 19920) and must not have stopped the treatment early before the end of that trial
- You must have a confirmed diagnosis of chronic kidney disease (CKD) at a certain level of kidney function (stages 1–3, meaning your kidneys are still working at least partially) at the start of this study
- You must already be taking a blood pressure medication called an ACE inhibitor or ARB, at the highest dose you can tolerate, and that dose must have stayed the same for at least 30 days before joining
- Your blood potassium level must be within a safe range — at or below 5.0 mmol/L if you are aged 2 or older, or at or below 5.3 mmol/L if you are under 2 years old, both at the end of the FIONA trial and at the start of this study
- If you are old enough to legally give consent yourself, you must be able to sign the consent form
- You must be able to eat or receive nutrition by mouth, bottle, cup, or through a feeding tube (with or without breastfeeding)
Who may not be able to join:
- You have a planned surgery on the urinary system that is expected to affect how your kidneys work
- You are scheduled to receive a kidney transplant within the timeframe of this study
- You have severely high blood pressure (Stage 2) at the start of the study
- You have dangerously low blood pressure, either with symptoms or measured below a certain level for your age, sex, and height (confirm with trial site)
- You have a known allergy or sensitivity to the study drug or any of its ingredients
- You have severe liver disease (for example, a Child-Pugh C score or similar) (confirm with trial site)
- You are currently taking certain immune-suppressing medications, including rituximab, cyclophosphamide, abatacept, or steroid infusions given through a vein
- You are currently taking certain other medications that affect the heart, kidneys, or potassium levels, including spironolactone, eplerenone, aliskiren, SGLT2 inhibitors, sacubitril/valsartan, amiloride, or triamterene (confirm with trial site for full list)
- You are taking both an ACE inhibitor and an ARB at the same time
- You are taking certain other medications that strongly interact with the way the body processes the study drug (confirm with trial site)
- You have already been assigned to a treatment in this study before
- You are currently taking part in another clinical trial involving a treatment or intervention
- You had a serious side effect related to the study drug during the FIONA trial that caused you to permanently stop taking it
- You are pregnant, breastfeeding, or planning to become pregnant during the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: (+)1-888-84 22937
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of participants with treatment emergent adverse event (TEAEs); Change in serum potassium levels from baseline to Day 540±7; Change in systolic blood pressure (SBP) from baseline to Day 540±7
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.