Atrasentan in patients with IgA nephropathy (ALIGN)
Atrasentan in patients with IgA nephropathy (ALIGN)
ClinicalTrials.gov ID: NCT04573478
Sponsor: Chinook Therapeutics U.S., Inc.
Information provided by: Chinook Therapeutics, Inc. (Chinook Therapeutics U.S., Inc.) (Responsible Party)
Last Update Posted: 2024-05-23
Brief Summary:
The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.
Detailed Description:
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.
Additional subjects receiving a stable dose of SGLT2i will be enrolled to the study. Enrollment in this SGLT2i stable stratum will be in accordance with local regulations in regions that prescribe SGLT2i and will be independent of the 320 subjects enrolled for the primary and secondary analyses.
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 treatment through Week 132 and complete the double-blinded portion of the study may be eligible to enroll in the open label extension of the study to receive atrasentan 0.75 mg daily for up to 48 weeks.
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function
Intervention / Treatment:
- Drug: Atrasentan
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2020-12-11
|
| Primary Completion (Actual) |
2023-09-07
|
| Study Completion (Estimated) |
2026-12-18
|
| Enrollment (Estimated) | 380 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CHK01-01
|