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A Randomized, Double-blind, Placebo-controlled, Crossover Study
of Atrasentan in Subjects with IgA Nephropathy on Sodiumglucose Cotransporter-2 Inhibitors (SGLT2i)

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Chronic kidney disease
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All genders
person-wave 18+
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Overview
Principal Investigator: Lesley Inker

This is a phase 2, randomized, double-blind, placebo-controlled, crossover study to evaluate the safety and efficacy of atrasentan vs placebo while on background therapy with SGLT2i in subjects with IgAN. The primary efficacy assessment is the change from baseline in proteinuria (UPCR) at week 12. Eligible subjects who are enrolled in the study will be randomly assigned in a 1 to 1 ratio to either sequence AB or sequence BA. Subjects assigned to sequence AB will orally take atrasentan once daily for 12 weeks, undergo a 12 week wash out period, and then orally take a placebo once daily for 12 weeks. Subjects assigned to sequence BA will orally take a placebo once daily for 12 weeks, undergo a 12 week wash out period, and then orally take atrasentan once daily for 12 weeks. Following the end of treatment, subjects will have follow-up evaluations for safety, approximately 4 weeks after the end of treatment. Subjects will be evaluated throughout the trial for efficacy, safety, pharmacokinetic, and immunogenicity assessments as well as exploratory biomarkers and pharmacogenomics.

Study details
Inclusion Criteria
  • Biopsy proven IgAN
  • Receiving a maximally tolerated and stable dose of a renin-angiotensin system
    inhibitor (RASi) for at least 12 weeks prior to screening
  • eGFR ≥ 30 mL/min/1.73 m^2 at screening based on the CKD-EPI equation
Exclusion Criteria
  • Concurrent diagnosis of another cause of chronic kidney disease including
    diabetic kidney disease or another primary glomerulopathy
  • Diagnosis of Type 1 diabetes
  • History of organ transplantation
Study Requirements

If you choose to join this study, you will be in the study for up to 64 weeks, which is about 16 months. You will be asked to complete up to 14 on-site study visits and up to 11 remote visits during that time. About 1 to 3 tablespoons of blood will be taken at certain visits. This is a double-blind, placebo-controlled, crossover study, meaning all participants will receive the active study drug at some point in the study as well as the placebo during another portion of the study.