Approximately 320 patients across North America, South America, Europe, and Asia-Pacific with IgA nephropathy will participate in the ALIGN study. Patients will be randomly assigned to receive atrasentan or placebo daily for 132 weeks and will also receive a maximally-tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor (such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)) as part of standard of care. Subjects who are unable to tolerate RAS inhibitor therapy will also be eligible to participate.
The ALIGN study will evaluate if atrasentan can reduce how much protein is in your urine and delay the worsening of kidney function. The study will also evaluate the safety and tolerability, as well as quality of life.
Patients will have assessments of safety and efficacy over 2 ½ years. To facilitate study participation over this period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
Patients who complete the study may be eligible to enroll in an extension study to receive open-label treatment with atrasentan under a separate protocol.