In short
Clinical trials are studying Atrasentan Hydrochloride in people with IgA nephropathy, a kidney disease that can cause protein in the urine and possible loss of kidney function. These studies look at whether it is safe and whether it can reduce proteinuria, especially in patients already taking an SGLT2 inhibitor. The trials include Phase 2 and Phase 3 research.
Key points
- Clinical trials of Atrasentan Hydrochloride are focused on IgA nephropathy, a kidney disease linked to protein in the urine and possible decline in kidney function. The data include one Phase 2 study and one Phase 3 study, showing both early and larger-scale research. One trial studied patients already taking an SGLT2 inhibitor, while the other studied patients at risk of progressive loss of renal function. The main outcome in both studies was change in proteinuria, measured by UPCR from a 24-hour urine collection. One study was completed with 54 participants, and the larger Phase 3 study enrolled 404 participants. The Phase 3 study also included an open-label extension to learn more about safety over time.
Trial overview
The available trials are studying Atrasentan Hydrochloride in people with IgA nephropathy, also called IgAN, which is a kidney disease that can lead to protein in the urine and loss of kidney function.
One study was a Phase 2 trial in people with IgA nephropathy who were taking an SGLT2 inhibitor, and the other was a Phase 3 study in patients with IgA nephropathy at risk of progressive loss of renal function.
Who was studied
The Phase 2 study focused on people with IgA nephropathy who were already taking dapagliflozin, which is listed in the trial data as an SGLT2 inhibitor.
The Phase 3 study included patients with IgA nephropathy who were at risk of progressive loss of kidney function, meaning their disease could get worse over time.
These trials were not broad kidney disease studies; they were focused on a specific kidney condition and a defined patient group.
Study designs and phases
The Phase 2 study was an interventional trial, which means researchers gave a study treatment and then measured the results.
The Phase 3 study was also interventional and was described as randomized, double-blind, and placebo-controlled.
Randomized means treatment groups were assigned by chance, double-blind means neither the participants nor the study team knew who got which treatment, and placebo-controlled means the study compared Atrasentan Hydrochloride with a look-alike treatment that did not contain the active study drug.
The Phase 3 study also included an open-label extension to further characterize safety, which means some participants could continue in a follow-up part of the study where the treatment is known and longer-term safety can be studied.
What was measured
Both trials mainly measured proteinuria, which means the amount of protein in the urine.
The studies used urine protein:creatinine ratio, or UPCR, from a 24-hour urine collection to track change from the start of the study to later time points.
In the Phase 2 study, the main outcome was the change from baseline to Week 12.
In the Phase 3 study, the main outcome was the change from baseline to Week 36 in the non-SGLT2i stratum, which means the group analyzed did not include patients on an SGLT2 inhibitor in that specific analysis.
Trial details
NCT05834738 was a Phase 2 study that enrolled 54 people and was completed.
This study compared Atrasentan Hydrochloride with matching placebo while participants were on background SGLT2 inhibitor therapy, and the summary says it was designed to evaluate efficacy versus placebo.
NCT04573478, also called the ALIGN Study, was a Phase 3 trial with 404 participants and was authorised.
This study compared Atrasentan Hydrochloride with placebo in patients with IgA nephropathy at risk of progressive loss of renal function, and it also included an open-label extension for more safety information.
Key points for patients
These trials are looking at whether Atrasentan Hydrochloride can help lower protein loss in the urine in people with IgA nephropathy.
The studies are designed to compare the study drug with placebo so researchers can see whether any change is linked to the treatment and not to chance alone.
Across the available data, the focus is on kidney outcomes and safety, with one smaller Phase 2 study and one larger Phase 3 study providing the main evidence base.