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Atrasentan Hydrochloride

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.

Table of Contents

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.[1][2]

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.[1][2]

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.[1]

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.[2]

These trials were not broad kidney disease studies; they were focused on a specific kidney condition and a defined patient group.[1][2]

Study designs and phases

The Phase 2 study was an interventional trial, which means researchers gave a study treatment and then measured the results.[1]

The Phase 3 study was also interventional and was described as randomized, double-blind, and placebo-controlled.[2]

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.[2]

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.[2]

What was measured

Both trials mainly measured proteinuria, which means the amount of protein in the urine.[1][2]

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.[1][2]

In the Phase 2 study, the main outcome was the change from baseline to Week 12.[1]

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.[2]

Trial details

NCT05834738 was a Phase 2 study that enrolled 54 people and was completed.[1]

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.[1]

NCT04573478, also called the ALIGN Study, was a Phase 3 trial with 404 participants and was authorised.[2]

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.[2]

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.[1][2]

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.[1][2]

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.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05834738 Phase 2 IgA nephropathy in people taking an SGLT2 inhibitor Completed 54
NCT04573478 Phase 3 IgA nephropathy at risk of progressive loss of renal function Authorised 404

FAQ

  • What is being studied in the Atrasentan Hydrochloride trials? The trials are studying whether Atrasentan Hydrochloride can lower proteinuria, which means too much protein in the urine, in people with IgA nephropathy. They also look at safety and, in one study, longer-term safety in an open-label extension.
  • Who can take part in these trials? The studies focus on people with IgA nephropathy, also called IgAN or Immunoglobulin A Nephropathy. One trial includes patients who are already taking an SGLT2 inhibitor, while the Phase 3 study looks at patients at risk of progressive loss of kidney function.
  • What phases are the Atrasentan Hydrochloride trials? The trial data include a Phase 2 study and a Phase 3 study. Phase 2 usually looks at early signs of benefit and safety, while Phase 3 tests the treatment in a larger group.
  • What outcome are the trials measuring? The main outcome in both trials is the change in proteinuria, measured by urine protein:creatinine ratio, or UPCR, from the start of the study to a later time point. This helps show whether kidney protein loss improves over time.
  • Are these trials comparing Atrasentan Hydrochloride with anything else? Yes. Both studies include placebo, which is a look-alike treatment with no active study drug. This helps researchers compare results fairly.

Ongoing Clinical Trials on Atrasentan Hydrochloride

  • Study on Atrasentan for Patients with IgA Nephropathy at Risk of Kidney Function Loss

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Portugal Spain

  • Study on the Safety and Effectiveness of Atrasentan for Patients with IgA Nephropathy Taking SGLT2 Inhibitors

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • IgA nephropathy (IgAN): A kidney disease that can cause protein in the urine and may lead to worsening kidney function over time.
  • Proteinuria: A medical term for having too much protein in the urine. It can be a sign of kidney damage or kidney disease.
  • Urine protein:creatinine ratio (UPCR): A urine test used to estimate how much protein is being lost in the urine. It is often used to follow kidney disease in studies.
  • Baseline: The starting point before treatment begins. Trial results are often compared with this starting value.
  • Week 12: A study time point 12 weeks after the trial starts, used to check early changes in outcomes.
  • Week 36: A study time point 36 weeks after the trial starts, used to check later changes in outcomes.
  • Placebo: A look-alike treatment that does not contain the study drug. It is used to compare results in a fair way.
  • Randomized: Participants are assigned by chance to different study groups, which helps make the comparison more reliable.
  • Double-blind: A study design where neither the participants nor the study team know who is receiving which treatment during the trial.
  • Open-label extension: A follow-up part of a study where participants may continue treatment and the main goal is often to learn more about safety over a longer time.
  • SGLT2 inhibitor (SGLT2i): A type of medicine some patients with kidney disease may already be taking. One trial studied Atrasentan Hydrochloride on top of this background treatment.

References