Research Project
Project Title: |
A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) |
Project Type: |
Clinical Trial, Enrolment ongoing |
Disease group(s): |
Hereditary glomerulopathies |
Project Summary: |
Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo daily for 132 weeks. Subjects 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. An exception will be made for subjects who are unable to tolerate RAS inhibitor therapy.The primary objective of the study is to evaluate the effect of atrasentan versus placebo on proteinuria as measured by UPCR. Secondary and tertiary objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability, as well as quality of life.Subjects will have assessments of safety and efficacy over 2 ½ years. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.Subjects who complete the study may be eligible to enroll in an extension study to receive open-label treatment with atrasentan under a separate protocol. |
Lead principal investigator(s): |
Myriam Dao, Paris Loreto Gesualdo, Bari |
Co-investigator(s): |
Bertrand Knebelmann, Paris Vincenzo Di Leo, Bari |
Project Period: |
12/2020 - 12/2026 |
Sponsors: |
Industry |
ClinicalTrials.gov: |
NCT04573478 |
EudraCT Nr.: |
2020-003084-26 |
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