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

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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 IgA nephropathy, which affects the kidneys' ability to filter waste from the blood. The study will evaluate a treatment using a medication called atrasentan, which is taken as a film-coated tablet. Participants in the study will also be on a type of medication known as SGLT2 inhibitors, which help control blood sugar levels and are often used in managing diabetes. Another medication involved in the study is dapagliflozin, which is also an SGLT2 inhibitor. Some participants will receive a placebo, which looks like the real medication but does not contain the active substance.

The purpose of the study is to determine if atrasentan is safe and effective for people with IgA nephropathy who are already taking an SGLT2 inhibitor. Participants will be randomly assigned to receive either atrasentan or a placebo, and the study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will follow a crossover design, where participants will switch from one treatment to the other during the study period.

The study will last for several weeks, with participants undergoing regular check-ups and tests to monitor their health and the effects of the treatment. The main focus will be on changes in protein levels in the urine, which is an important indicator of kidney function. By the end of the study, researchers hope to gather valuable information about the potential benefits and safety of atrasentan for treating IgA nephropathy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must be at least 18 years old and provide written informed consent.
The participant must be willing to comply with all study visits and procedures.
Step 2
Run-in period
The participant will undergo an 8-week run-in period with a sodium-glucose cotransporter-2 inhibitor (SGLT2i).
During this period, the participant must maintain a stable and well-tolerated dose of the SGLT2i.
Step 3
End of run-in period assessment
At the end of the run-in period, the participant's 24-hour urine protein must be greater than 0.5 grams per day.
The participant's estimated glomerular filtration rate (eGFR) must be at least 30 mL/min/1.73 m².
Step 4
Treatment period 1
The participant will receive either atrasentan or a placebo in the form of film-coated tablets, taken orally.
The treatment will last for 12 weeks, with the primary goal of evaluating changes in protein levels in the urine.
Step 5
Crossover to treatment period 2
After completing treatment period 1, the participant will switch to the alternate treatment (either atrasentan or placebo) for another 12 weeks.
The secondary goal is to assess changes in protein levels in the urine from baseline to week 24.
Step 6
Completion of study
The study is estimated to end by May 25, 2026.
Participants will be monitored for any changes in their condition and overall health throughout the study duration.

Who can join the trial?

12 criteria

Must be aged 18 or older at the time of signing the informed consent form.
Willing to participate in an 8-week period with a medication called SGLT2i.
Must complete the 8-week period on a stable and well-tolerated dose of SGLT2i.
Must have more than 0.5 grams of protein in their urine over 24 hours, confirmed at a specific visit.
Must have an estimated glomerular filtration rate (eGFR) of 30 or more. eGFR is a test that measures how well the kidneys are working.
Must have a kidney biopsy that shows IgAN, which is a specific kidney condition, and it should not be due to other causes. A biopsy is a small sample of tissue taken for testing.
Must be taking a stable dose of a medication called renin-angiotensin system inhibitor (RASi) for at least 12 weeks before the study starts.
Must agree to use effective birth control methods during the study and for up to 1 month afterward.
Must be willing and able to provide written consent and follow all study visits and procedures.
If already taking SGLT2i, must be on a stable dose for at least 8 weeks before the study starts.
If already taking SGLT2i, must have more than 0.5 grams of protein in their urine over 24 hours.
If participating in the 8-week period, must have more than 0.85 grams of protein in their urine over 24 hours at the start.

Who cannot join the trial?

9 criteria

Patients with severe kidney problems that are not stable.
Patients who have had a kidney transplant.
Patients with uncontrolled high blood pressure.
Patients with a history of heart failure, which means the heart doesn't pump blood as well as it should.
Patients with liver disease, which affects how the liver works.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hospital Del Mar
Barcelona, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario De Getafe
Getafe, Spain

Trial locations

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Investigated drugs

Atrasentan
is a medication being studied for its potential to help people with IgA nephropathy, a kidney disease. It is being tested to see if it can improve kidney function when used alongside other treatments.
Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
are a group of medications that help lower blood sugar levels in people with diabetes. In this study, they are used as a background therapy to see how well they work with atrasentan in treating IgA nephropathy.

What is already known about the treatment

Atrasentan – Atrasentan is administered orally in tablet form. It is currently being studied in clinical trials, particularly for its potential benefits in nephrology, specifically IgA nephropathy. The main therapeutic indication for atrasentan is to help manage kidney conditions by reducing proteinuria, which is an excess of protein in the urine. At the molecular level, atrasentan works by blocking the endothelin receptor, which plays a role in constricting blood vessels and promoting inflammation. This medication is classified as an endothelin receptor antagonist.

Investigated diseases

Chronic Kidney Disease – Chronic Kidney Disease (CKD) is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses through stages, starting with mild damage and potentially advancing to severe kidney failure. As the disease progresses, waste products can build up in the body, leading to symptoms such as fatigue, swelling in the legs, and high blood pressure. The progression of CKD can be slow, and symptoms may not appear until significant kidney damage has occurred. Regular monitoring of kidney function is essential to understand the progression of the disease.