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.
The ADU-CL-19 Study
Chinook Therapeutics, ADU-CL-19 Short Summary — IGAN Foundation of America
Chinook Therapeutics, Inc. is developing BION-1301,an investigational IgG4 humanized monoclonal antibody that blocks A Proliferation-Inducing Ligand, or APRIL. Studies have shown high levels of APRIL correlate with poor prognoses in patients with IgA nephropathy (IgAN), a chronic autoimmune kidney disease.
ADU-CL-19 is a Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy. The primary objective of the trial is to assess the safety, pharmacokinetics and pharmacodynamics of BION-1301 in healthy volunteers and patients with IgAN.
In Part 3 of the trial, patients with IgAN will be randomized into two cohorts receiving BION-1301 at differing doses and frequency in an open-label manner. Enrolled patients will receive three months of dosing with BION-1301 (IV formulation) and three months of follow-up. The trial duration is expected to be 24 weeks with sites in both the US and UK. Patients enrolled in Part 3 of the study may be eligible to continue dosing for up to 24 months through participation in an Open Label Extension study the sponsor is opening.
If you are an adult patient with IgAN who meets these eligibility criteria and are interested in participating in this study, additional information may be found on ClinicalTrials.gov (Identifier: NCT03945318) and https://www.chinooktx.com/patients/iga-nephropathy/.