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Study on the Effectiveness and Safety of Sparsentan and Dapagliflozin for Patients with Immunoglobulin A Nephropathy (IgAN)

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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 the effectiveness and safety of a medication called Sparsentan for treating a kidney disease known as Immunoglobulin A Nephropathy (IgAN). IgAN is a condition where a protein called immunoglobulin A builds up in the kidneys, leading to inflammation and potential kidney damage. The study aims to see how well Sparsentan can reduce protein levels in the urine and help maintain kidney function compared to another type of medication called an angiotensin receptor blocker (ARB), which is commonly used to treat high blood pressure and kidney issues.

Participants in the study will be randomly assigned to receive either Sparsentan or an ARB. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not biased. The study will also include a period where participants can receive Sparsentan openly, allowing researchers to assess its long-term effects. Additionally, some participants may be involved in a sub-study to evaluate the combination of Sparsentan with another medication called Dapagliflozin, which is used to manage blood sugar levels in people with diabetes.

The trial will monitor changes in the amount of protein in the urine and kidney function over time. Participants will take the medication in tablet form by mouth. The study will last for several months, with regular check-ups to ensure the safety and effectiveness of the treatment. The goal is to gather information that could lead to better treatment options for people with IgAN.

The research process

The trial runs in 6 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, participation begins in the double-blind period. This means neither the patient nor the researchers know which treatment is being administered. The study focuses on the treatment of Immunoglobulin A Nephropathy (IgAN).

  2. Step 2

    Double-blind period

    During this period, the patient receives either sparsentan or an angiotensin receptor blocker (ARB) in tablet form, taken orally. The specific dosage and frequency are determined by the study protocol.

    The primary goal is to assess the effect of sparsentan on protein levels in urine and kidney function. Safety and tolerability are also monitored.

  3. Step 3

    Monitoring and assessments

    Regular assessments are conducted to monitor changes in urine protein levels and kidney function. Blood pressure and other vital signs are also checked.

    The primary efficacy endpoint is the change in the urine protein/creatinine ratio at Week 36.

  4. Step 4

    Open-label extension period

    If the patient completes the double-blind period, they may enter the open-label extension period. Here, all patients receive sparsentan, and both the patient and researchers know the treatment being administered.

    The focus is on long-term efficacy, safety, and tolerability of sparsentan.

  5. Step 5

    Sparsentan + SGLT2 inhibitor sub-study

    Eligible patients may participate in a sub-study involving sparsentan and an SGLT2 inhibitor, such as dapagliflozin. This involves additional monitoring and assessments.

    The sub-study aims to further evaluate the combination's effect on urine protein levels and kidney function.

  6. Step 6

    End of study

    The study is estimated to conclude by July 28, 2026. Final assessments will be conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

15 criteria

  • Must be a male or female aged 18 years or older.
  • Must have a confirmed diagnosis of **Immunoglobulin A Nephropathy (IgAN)** through a kidney biopsy.
  • Must have a urine protein excretion value of at least 1.0 grams per day at the start of the study. This means the amount of protein in the urine is measured to be 1.0 grams or more each day.
  • Must have an **eGFR** value of at least 30 mL/min/1.73 m² at the start of the study. **eGFR** is a test that measures how well the kidneys are working.
  • Must have been on a stable dose of **ACEI** (Angiotensin-Converting Enzyme Inhibitor) and/or **ARB** (Angiotensin Receptor Blocker) therapy for at least 12 weeks before the study starts. These are types of medications used to treat high blood pressure and kidney problems.
  • Must have a systolic blood pressure of 150 mmHg or lower and a diastolic blood pressure of 100 mmHg or lower at the start of the study. Systolic blood pressure is the top number, and diastolic is the bottom number in a blood pressure reading.
  • Women of childbearing potential must agree to use two forms of contraception to prevent pregnancy during the study.
  • Must be willing and able to provide signed informed consent to participate in the study. This means agreeing to join the study after understanding all the details and risks involved.
  • For the **Open-Label Extension Period**, the patient must not have permanently stopped taking the study medication during the initial study period.
  • For the **Open-Label Extension Period**, the patient must have completed participation in the initial study period, including specific visits at Week 110 and Week 114.
  • For the **Sparsentan + SGLT2 Inhibitor Sub-study**, the patient must have a urine protein excretion value of at least 0.3 grams per day.
  • For the **Sparsentan + SGLT2 Inhibitor Sub-study**, the patient must have an **eGFR** of at least 25 mL/min/1.73 m².
  • For the **Sparsentan + SGLT2 Inhibitor Sub-study**, the patient must be on a stable dose of sparsentan for at least 8 weeks at the maximum tolerated dose.
  • For the **Sparsentan + SGLT2 Inhibitor Sub-study**, the patient must have at least 12 weeks of the study remaining.
  • For the **Sparsentan + SGLT2 Inhibitor Sub-study**, the patient must meet local requirements and not have any reasons that would prevent them from taking dapagliflozin, a type of medication.

Who cannot join the trial?

10 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 study is looking for participants within certain age groups.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a kidney transplant cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.
  • Patients who have uncontrolled high blood pressure cannot participate.
  • Patients who have severe liver disease cannot participate.
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Investigated drugs

Sparsentan is a medication being studied for its ability to reduce protein levels in the urine and help preserve kidney function in patients with Immunoglobulin A Nephropathy (IgAN). The study aims to evaluate how well sparsentan works in comparison to another type of medication known as an angiotensin receptor blocker (ARB). Additionally, the study will monitor the safety and tolerability of sparsentan over time, both in a controlled setting and in an open-label phase where all patients receive sparsentan.

What is already known about the treatment

Sparsentan – Sparsentan is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness and safety in treating Immunoglobulin A Nephropathy (IgAN). The main therapeutic indication for sparsentan is to reduce proteinuria and preserve kidney function in patients with IgAN. At the molecular level, sparsentan works by blocking both endothelin and angiotensin II receptors, which helps to reduce blood pressure and protein leakage in the kidneys. It is classified pharmacologically as a dual endothelin receptor and angiotensin 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 glomeruli, the tiny filtering units within the kidneys. The disease often progresses slowly over many years, and symptoms may not be noticeable in the early stages. As the condition advances, it can lead to blood and protein in the urine, high blood pressure, and swelling in the hands and feet. The progression of IgAN can vary significantly among individuals, with some experiencing only mild symptoms while others may develop more severe kidney damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505495-30-00Protocol code021IGAN17001Estimated enrolment403 patientsSponsorTravere Therapeutics Inc.

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