Are you living with IgA nephropathy?
The APRICOT study is an open-label, single-arm, multicenter Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and tolerability of iptacopan in pediatric patients aged 2 to under 18 years with primary immunoglobulin A nephropathy (IgAN). The goal of the study is to see if iptacopan has an effect on how well your kidneys work by measuring the level of protein in your urine (proteinuria). The study is also planning to see if iptacopan is safe and well tolerated in patients with IgAN.
About 24-34 pediatric participants will take part in this study worldwide. This study will be conducted at about 22 study centers worldwide. Participation in the study involves up to 11 visits over the course of
15 months, including up to 12 months of treatment with Iptacopan. Participants who qualify may be reimbursed for their time and travel costs, such as mileage and lodging, for taking part in the clinical study.
Who Can Join?
You may qualify to participate in this study if you are:
- Age between 2 and under 18 years on Day 1
- Have been diagnosed with IgA nephropathy by kidney biopsy
- Have a urine protein creatinine ratio (UPCR) of ≥ 1 g/g
- stable dose of ACE inhibitor or ARB (maximally approved or tolerated) for at least 120 days before Day 1
- eGFR of >/= 30 mL/min/1.73 m2
- Willingness to use contraception
Currently Open
Learn More Here