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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a kidney disease called Immunoglobulin A Nephropathy (IgA Nephropathy), which can lead to a gradual loss of kidney function. The study is testing a treatment called atrasentan, which is taken as a film-coated tablet. The purpose of the study is to evaluate how well atrasentan works compared to a placebo in reducing the amount of protein in the urine, which is a sign of kidney damage.

Participants in the study will be randomly assigned to receive either atrasentan or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will last for a period of time, during which participants will have regular check-ups to monitor their kidney function and overall health. There is also an open-label extension phase, where all participants can receive atrasentan to further assess its safety.

The main goal is to see if atrasentan can help reduce protein levels in the urine and slow down the progression of kidney damage. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how the treatment affects their condition. This study aims to provide valuable insights into the potential benefits of atrasentan for people with IgA Nephropathy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either atrasentan or a placebo. Both are administered as film-coated tablets for oral use.

    The study is designed to be double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

  2. Step 2

    Treatment phase

    The patient will take the assigned tablet once daily. The exact dosage will be determined by the study protocol.

    The treatment phase will last until Week 136, with regular monitoring and assessments to track the patient's response to the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor kidney function and protein levels in the urine. This includes 24-hour urine collections to measure proteinuria.

    The primary goal is to evaluate changes in proteinuria from baseline to Week 36.

  4. Step 4

    End of treatment

    At the end of the treatment phase, the patient will have a final study visit at Week 136, which is 4 weeks after the end of treatment.

    During this visit, the patient's kidney function will be assessed using the eGFR (estimated glomerular filtration rate) to determine any changes from the baseline.

  5. Step 5

    Open label extension

    Patients who complete the double-blind portion of the study may be eligible to enter an open-label extension phase.

    In this phase, all patients will receive atrasentan to further evaluate its safety and effects over a longer period.

Who can join the trial?

10 criteria

  • Men and women aged 18 and older can participate.
  • Participants must have a confirmed diagnosis of **Immunoglobulin A Nephropathy (IgAN)**, which is a kidney condition, not caused by other secondary reasons. A diagnostic report must be available for review.
  • Participants should be receiving the highest dose they can tolerate of a **RAS inhibitor**, a type of medication for blood pressure and kidney protection, which has been stable for at least 12 weeks before the study starts. If they cannot tolerate RAS inhibitors, they can still participate, but this group will be limited.
  • Participants must have a total urine protein level of at least 1 gram per day, measured through a 24-hour urine collection at the start of the study.
  • Participants need to have an **eGFR** (a test that measures kidney function) of at least 30 mL/min/1.73 m² at the start of the study.
  • All fertile men and women of childbearing potential (WOCBP) who engage in heterosexual intercourse must agree to use highly effective contraception during the study and for 1 month afterward. Women must have started using hormonal contraceptives at least 1 month before the study begins.
  • Participants must be willing and able to provide written informed consent and agree to attend all study visits and follow study procedures.
  • For those in the **Open Label Extension** part of the study, participants must have completed the initial part of the study through Week 132 and the Week 136 visit. They must enroll in the extension within 14 days of Week 136. If there are delays, they may still join if less than 90 days have passed since their last visit, with approval.
  • Participants in the Open Label Extension must provide written informed consent for this part and agree to comply with all study visits and procedures.
  • For the **SGLT2i Stable Stratum**, participants must be on a stable dose of an **SGLT2i** (a type of medication for diabetes and kidney protection) along with a stable dose of a RAS inhibitor for at least 12 weeks before the study starts.

Who cannot join the trial?

4 criteria

  • Patients who have a different kidney condition other than Immunoglobulin A Nephropathy (IgAN) cannot participate. IgAN is a disease that affects the kidneys.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial group cannot participate. This refers to a specific group of people the study is focusing on.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups who may need special protection or care.
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Investigated drugs

Atrasentan is a medication being studied for its potential to help patients with IgA nephropathy, a kidney condition that can lead to progressive loss of kidney function. The trial aims to see if atrasentan can reduce the amount of protein in the urine, which is a sign of kidney damage. The study also includes an open-label extension to gather more information about the safety of using atrasentan over a longer period.

What is already known about the treatment

Atrasentan – Atrasentan is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating Immunoglobulin A Nephropathy (IgAN), a kidney disease that can lead to progressive loss of renal function. The main therapeutic indication for atrasentan is to reduce proteinuria, which is the presence of excess proteins in the urine, a common symptom of IgAN. At the molecular level, atrasentan works by blocking the endothelin receptor, which is involved in the constriction of blood vessels and inflammation, thereby potentially reducing kidney damage. It is classified pharmacologically as an endothelin receptor antagonist.

Investigated diseases

Immunoglobulin A Nephropathy (IgAN) – This is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation that can affect the kidneys' ability to filter waste from the blood. Over time, this buildup can cause damage to the kidney tissues, resulting in symptoms such as blood in the urine, protein in the urine, and swelling in the hands and feet. The disease progresses at varying rates, with some individuals experiencing slow progression over many years, while others may see a more rapid decline in kidney function. The exact cause of IgAN is not fully understood, but it is believed to involve a combination of genetic and environmental factors. As the disease advances, it can lead to chronic kidney disease and potentially kidney failure if not managed appropriately.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513227-16-00Protocol codeCEXV811A12301Estimated enrolment404 patientsSponsorNovartis Pharma AG

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