BASELINE CHARACTERISTICS OF THE ALIGN TRIAL: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF ATRASENTAN IN PATIENTS WITH IGAN

E-Poster

https://storage.unitedwebnetwork.com/files/1099/e56c803abf913e316ec7b2d5eafe6b4d.pdf

Abstract Title

First Name *

Hiddo J. L.

Last Name *

Heerspink

Co-author 1

Meg Jardine meg.jardine@sydney.edu.au University of Sydney NHMRC Clinical Trials Centre Sydney

Co-author 2

Donald E. Kohan donald.kohan@hsc.utah.edu University of Utah Health Sciences Center Division of Nephrology Salt Lake City

Co-author 3

Richard A. Lafayette czar@stanford.edu Stanford University Stanford Glomerular Disease Center Stanford

Co-author 4

Adeera Levin ALevin@providencehealth.bc.ca The University of British Columbia Division of Nephrology Vancouver

Co-author 5

Adrian Liew draliew2@gmail.com Mount Elizabeth Novena Hospital Renal Medicine Singapore

Co-author 6

Hong Zhang hongzh@bjmu.edu.cn Peking University First Hospital Renal Division Beijing

Co-author 7

Todd Gray tgray@chinooktx.com Chinook Therapeutics, a Novartis Company Biostatistics Seattle

Co-author 8

Khushboo Sheth ksheth@chinooktx.com Chinook Therapeutics, a Novartis Company Clinical Development Seattle

Co-author 9

Marianne Camargo mcamargo@chinooktx.com Chinook Therapeutics, A Novartis Company Clinical Development Seattle

Co-author 10

Ronny Renfurm ronny.renfurm@novartis.com Novartis Pharma AG Cardio-Renal Metabolism Global Drug Development Basel

Co-author 11

Andrew King aking@chinooktx.com Chinook Therapeutics, A Novartis Company Research and Development Seattle

Co-author 12

Jonathan Barratt jb81@leicester.ac.uk University Hospitals of Leicester NHS Trust Department of Cardiovascular Sciences, Renal Medicine Leicester

Co-author 13

Co-author 14

Co-author 15

Introduction

Endothelin A (ETA) receptor activation drives proteinuria, kidney inflammation and fibrosis in IgA nephropathy (IgAN). Atrasentan, a potent and selective ETA receptor antagonist, is a potential therapy to reduce proteinuria and preserve kidney function in patients with IgAN. Interim results from the IgAN cohort of the open-label AFFINITY study demonstrated atrasentan was well tolerated and resulted in clinically meaningful proteinuria reductions at 12 and 24 weeks. The ongoing ALIGN study (NCT04573478) is a global, phase 3, randomized, double-blind, placebo-controlled clinical trial of atrasentan in patients with IgAN at high risk of kidney function loss. Demographics and baseline characteristics will be presented.

Methods

Eligibility criteria for the ALIGN study include biopsy-proven IgAN, total protein excretion ≥ 1 g/d, eGFR ≥30 mL/min/1.73 m2 and receiving a maximally tolerated and stable dose of a renin-angiotensin system inhibitors (RASi). An additional stratum of patients also receiving a stable dose of sodium glucose cotransporter-2 inhibitors (SGLT2i) for at least 12 weeks are eligible. After randomization, patients receive 0.75 mg atrasentan or placebo daily for 132 weeks. The primary outcome is proteinuria change from baseline to Week 36. Key secondary and exploratory endpoints include eGFR change from baseline to week 136, safety and tolerability, and quality of life.

Results

The pre-specified interim analysis population included the first 270 patients enrolled in the main stratum. An additional 64 patients were enrolled in the exploratory SGLT2i stratum. Demographics and baseline characteristics were similar across both strata and will be presented at the time of the conference.

Conclusions

The global ALIGN trial has recruited patients with IgAN that are representative of a typical IgAN patient population. The inclusion of patients receiving maximally tolerated RASi and a stratum of patients receiving SGLT2i in addition to RASi reflects the current treatment paradigm in IgAN. This trial is ongoing and will report results at a future date.

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