Europas førende søgning efter kliniske forsøg

Atrasentan Hydrochloride

Clinical trials are studying Atrasentan Hydrochloride in people with IgA nephropathy, a kidney disease that can lead to loss of kidney function. These studies mainly look at whether the treatment is safe and whether it lowers protein in the urine. The trials include adults in Phase 2 and Phase 3 settings, with some participants also taking an SGLT2 inhibitor.

Table of contents

Overview of the trials

The available trials are studying Atrasentan Hydrochloride in people with IgA nephropathy, a kidney disease that can lead to progressive loss of renal function.[1][2]

Both studies are designed to see whether the treatment can reduce proteinuria, which means too much protein in the urine, and to learn more about safety and effectiveness.[1][2]

Conditions being studied

One trial enrolled people with IgA nephropathy who were already taking an SGLT2 inhibitor, which is a medicine used in some kidney-related treatment plans.[1]

The other trial studied patients with IgA nephropathy who were at risk of progressive loss of renal function, meaning their kidney function could get worse over time.[2]

Study design and phases

NCT05834738 was a Phase 2 interventional study with 54 participants and was completed.[1]

NCT04573478 was a Phase 3 randomized, double-blind, placebo-controlled study with 404 participants and was authorised.[2]

Randomized means people are assigned to study groups by chance, and double-blind means neither the participants nor the study team know who receives the study drug or placebo during the main part of the trial.[2]

The Phase 3 study also included an open-label extension, which means participants could continue in a follow-up period where the treatment is known, to help further describe safety.[2]

Who can participate

The trial data show that the studies are for people with IgA nephropathy, and one study specifically included people taking an SGLT2 inhibitor.[1]

The larger Phase 3 study focused on patients at risk of progressive loss of kidney function, so it targeted people with a more serious disease course.[2]

Main endpoints and what they mean

The main endpoint in both studies was proteinuria, measured by the urine protein:creatinine ratio, also called UPCR.[1][2]

In the Phase 2 study, the key measurement was the change in UPCR from baseline to Week 12.[1]

In the Phase 3 study, the key measurement was the change in UPCR from baseline to Week 36 in the non-SGLT2i stratum, which means the group not taking an SGLT2 inhibitor.[2]

These measurements help researchers see whether the treatment lowers protein loss in the urine, which is an important sign in kidney disease research.[1][2]

Key trial details

Trial ID Title Phase Status Enrollment Main focus
NCT05834738 A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2i Phase 2 Completed 54 Compare Atrasentan Hydrochloride with placebo while participants are on background SGLT2 inhibitor therapy.
NCT04573478 A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) Phase 3 Authorised 404 Compare Atrasentan Hydrochloride with placebo and further describe safety in an extension period.

Patient-friendly terms

Interventional study means researchers give a treatment and then measure what happens.[1][2]

Placebo means a look-alike treatment without the active study drug, used for comparison.[1][2]

Enrollment is the number of people who joined the study.[1][2]

Primary outcome is the main result the researchers want to measure.[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 condition is being studied in the Atrasentan Hydrochloride trials? The trials are studying IgA nephropathy, also called IgAN. This is a kidney condition, and the studies focus on people at risk of worsening kidney function.
  • What are the main goals of these trials? The main goals are to see whether Atrasentan Hydrochloride is safe and whether it works. The studies measure proteinuria, which means protein in the urine, as a key sign of kidney disease activity.
  • What phases are the trials in? The trial data includes a Phase 2 study and a Phase 3 study. Phase 2 usually looks more closely at early effectiveness and safety, while Phase 3 studies a larger group to confirm results.
  • Who can take part in these studies? The studies are for people with IgA nephropathy. One trial includes people who are taking an SGLT2 inhibitor, and another focuses on patients at risk of progressive loss of renal function.
  • What outcome do the trials measure? The main outcome is the change in proteinuria, measured by the urine protein:creatinine ratio, or UPCR. This is checked over time to see whether the treatment reduces protein loss in the urine.

Igangværende kliniske forsøg for Atrasentan Hydrochloride

  • Test af lægemidlet atrasentan til behandling af nyresygdommen IgA-nefropati

    Rekrutterer

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig Tyskland Italien Polen Portugal Spanien

  • Undersøgelse af om lægemidlet atrasentan kan hjælpe personer med nyresygdommen IgA-nefropati, som tager SGLT2-hæmmere

    Rekrutterer ikke

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Spanien

Ordliste

  • IgA nephropathy (IgAN): A kidney disease in which the body's immune system is involved. It can slowly damage the kidneys over time.
  • Proteinuria: Too much protein in the urine. This can be a sign that the kidneys are not working normally.
  • Urine protein:creatinine ratio (UPCR): A urine test used to estimate how much protein is being lost in the urine.
  • Baseline: The starting point of a study, before the trial treatment is measured.
  • Week 12: A time point 12 weeks after the study starts, used to check results.
  • Week 36: A time point 36 weeks after the study starts, used to check results.
  • Placebo: A treatment that looks like the study medicine but does not contain the active drug.
  • Randomized: Participants are assigned by chance to different study groups.
  • Double-blind: Neither the participants nor the study team know who gets the study drug or placebo during the trial.
  • SGLT2 inhibitor (SGLT2i): A type of medicine used in some kidney and diabetes-related treatment plans. One trial studied Atrasentan Hydrochloride while participants were already taking one.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/undersogelse-af-om-laegemidlet-atrasentan-kan-hjaelpe-personer-med-nyresygdommen-iga-nefropati-som-tager-sglt2-haemmere/
  2. https://kliniske-forsoeg.dk/forsog/test-af-laegemidlet-atrasentan-til-behandling-af-nyresygdommen-iga-nefropati/