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ATRASENTAN:
ALIGN and AFFINITY

Atrasentan is an Endothelin A (ETA) receptor antagonist which has been studied extensively in diabetic kidney disease and has shown to decrease proteinuria when administered on top of maximally tolerated Renin angiotensin System inhibitor (RASi) Selective ETA blockade represents a promising approach targeting HIT 4 in the pathogenesis of IgAN to reduce proteinuria and preserve kidney function in high risk IgAN patients.

Wavy Abstract Background

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Chinook Therapeutics

(206) 485-7051

clinicaltrials@chinooktx.com

AFFINITY

The AFFINITY study is a global, phase 2, open-label basket study to evaluate efficacy and safety of atrasentan in IgAN, FSGS, Alport syndrome and DKD patients at risk of progressive loss of kidney function.  The primary objective is to evaluate the effect of atrasentan on change in proteinuria (IgAN, FSGS, AS) or albuminuria (DKD) from baseline at Week 12.

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A Basket trial is a trial designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics.

 

Patients were treated orally with 0.75mg Atresentan daily for 52 weeks. 

Interim analysis of 20 patients showed that 79% of patients achieved >40% reduction in proteinuria at Week 24



ALIGN

Based on the results of the AFFINITY study, ALIGN study is a currently enrolling/ongoing global, phase 3, randomized, double-blind, placebo-controlled study of Atrasentan in patients with IgAN who are at high risk of kidney function loss. Approximately 320 patients will be enrolled across North America, South America, Europe, and Asia-Pacific.

 

After 6 weeks of screening period, patients will be randomized 1:1 between Atrasentan 0.75 mg oral daily vs matched placebo for 132 weeks. The primary objective of ALIGN study is to evaluate the effect of Atrasentan versus placebo on proteinuria at Week 24. Secondary objectives include evaluating the change in eGFR over time, safety, and tolerability, as well as quality of life.

Eligibility Criteria

  1. Biopsy-proven IgAN with total protein excretion ≥ 1 g per 24 hrs and eGFR ≥30 mL/min/1.73 m2 

  2. Receiving max-tolerated and optimized dose of RASi for at least 12 weeks prior to screening; a limited number of patients (up to 5%) that are unable to tolerate RASi therapy may be enrolled 

  3. An additional stratum of up to 64 patients receiving a stable dose of SGLT2i for at least 12 weeks will be enrolled

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