Phase 3 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children aged 6 months to under 18 years old at the time of signing the consent form.
• Children who have been diagnosed with chronic kidney disease (CKD), a condition where the kidneys do not work as well as they should, meeting specific kidney function levels based on age and stage of disease (confirm with trial site for exact measurements).
• Children whose kidney function has remained stable between the initial screening visit and the study start date, based on specific blood test measurements (confirm with trial site for exact values).
• Children who are already being treated with a blood pressure medication called an ACE inhibitor or an ARB, at the highest dose they can tolerate within recommended guidelines, with no change in dose for at least 30 days before screening.
• Children whose blood potassium levels are within an acceptable range at both the screening visit and the study start date — the acceptable level varies slightly depending on the child's age (confirm with trial site for exact values).
• Children who have significant levels of protein leaking into their urine, measured at specific thresholds that vary by age and kidney disease stage (confirm with trial site for exact values).

Who may not be able to join:

• Children who have planned surgery on the urinary system that is expected to affect how the kidneys work.
• Children diagnosed with a condition called hemolytic uremic syndrome (HUS) within the 6 months before screening.
• Children with nephrotic syndrome (a kidney condition causing significant protein loss) who have received albumin infusions within the 6 months before screening.
• Children who are scheduled to receive a kidney transplant during the period covered by the study.
• Children who already have a transplanted kidney.
• Children with a condition called bilateral renal artery stenosis, where the blood vessels supplying both kidneys are narrowed.
• Children who needed dialysis due to sudden kidney failure within the 6 months before screening.
• Children aged 1 year and older with severely high blood pressure (Stage 2 hypertension) at either the screening visit or the study start date.
• Infants aged 6 months to under 1 year with a systolic blood pressure above 110 mmHg at either the screening visit or the study start date.
• Children with blood pressure that is too low — specifically, below the 5th percentile for their age, sex, and height, or below 80 mmHg, at either the screening visit or the study start date.
• Children with immune-related kidney disease who have been treated with certain medications — including rituximab, cyclophosphamide, abatacept, or high-dose steroids — within the 6 months before screening.

Important: Always verify eligibility with the trial site directly before applying.