A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy (PROTECT)
IgA nephropathy is an autoimmune condition where proteins build up in the kidneys, causing inflammation and damage. Over time, this damage allows protein to spill into the urine and can lead to kidney failure. This study, known as the PROTECT trial, compares a new daily medicine called sparsentan with an existing treatment called irbesartan. The main goal is to find out if sparsentan can lower the amount of protein leaking into the urine after 36 weeks of treatment. The study also looks at long-term kidney function and quality of life over more than two years. Later parts of the study include an open-label extension where participants can take sparsentan, as well as a sub-study exploring sparsentan alongside another kidney drug called dapagliflozin. Adults aged 18 and over with IgA nephropathy may be eligible to take part.
At a glance
What is this study about?
Your kidneys contain millions of tiny filtering units that clean waste from your blood. In IgA nephropathy, an immune protein called immunoglobulin A settles in these delicate filters. This causes inflammation, which damages the kidney tissues. When damaged, the kidneys allow valuable proteins to leak out into your urine. Over many years, this ongoing stress can cause scarring and lead to kidney failure.
Currently, doctors use blood pressure tablets like irbesartan to reduce pressure in the kidney filters and slow down damage. Sparsentan is a newer medicine designed to block two different pathways involved in kidney stress and blood vessel tightening. Scientists hope that by blocking both pathways at once, sparsentan will provide stronger kidney protection than current standard treatments.
This study compares sparsentan directly against irbesartan to see which drug reduces urine protein more effectively. Researchers also track long-term kidney filtering speed (eGFR), blood pressure, and overall quality of life. In additional parts of the study, researchers look at adding an SGLT2 inhibitor (dapagliflozin) to see if combining these treatments offers even greater kidney protection.
Key takeaways
- Tests whether the new drug sparsentan protects kidneys better than the standard medicine irbesartan.
- Aimed at adults aged 18 and older diagnosed with IgA nephropathy.
- Measures how well treatments lower protein levels in urine and preserve kidney function.
- Involves daily tablets, regular hospital check-ups, and routine blood and urine tests.
- Includes long-term follow-up and sub-studies combining treatments for extra kidney protection.
Who may be eligible?
This trial is open to adults aged 18 and over who have a confirmed medical diagnosis of IgA nephropathy. Participants must have noticeable amounts of protein leaking into their urine despite receiving care.
You cannot join if you have certain other severe kidney problems, recent unstable heart conditions, or are taking medications that cannot be safely combined with the study drugs. Women who are pregnant or planning to become pregnant are not able to take part due to potential risks to an unborn baby.
Your kidney specialist or trial doctor will review your full medical history, blood results, and urine samples to decide safely whether this study is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with IgA nephropathy.
- I have protein showing up in my urine tests.
- I am able to attend regular clinic visits for blood and urine checks.
- I am not currently pregnant or planning a pregnancy during the trial.
What does participation involve?
If you take part, you will be placed into a treatment group by chance (randomly). Neither you nor your doctor will know whether you are taking sparsentan or the standard medicine, irbesartan, during the main part of the trial. You will take study tablets by mouth once a day. You will need to visit the hospital clinic regularly for routine tests, including blood tests to check your kidney function, blood pressure checks, and urine collections to measure protein levels. You will also complete short questionnaires about your daily wellbeing. The main phase lasts over two years, followed by an optional extension where participants can receive sparsentan directly. A smaller group may also take dapagliflozin alongside sparsentan.
Potential risks and benefits
Locations (11)
- —UnverifiedPoland
- —UnverifiedPortugal
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedLithuania
- —UnverifiedCzechia
- —UnverifiedItaly
- —UnverifiedCroatia
- —UnverifiedEstonia
- —UnverifiedSpain
Common questions
What is IgA nephropathy?
It is a kidney condition where natural immune proteins build up in the kidneys, causing swelling and allowing protein to leak into your urine.
Will I definitely receive the new medicine?
In the first part of the study, you are randomly assigned to receive either the new medicine (sparsentan) or a proven standard treatment (irbesartan). In the later extension period, participants can receive sparsentan.
What does a double-blind study mean?
It means neither you nor your study doctor will know which of the two study medicines you are taking, which ensures the test results remain completely fair and unbiased.
Will taking part cost me anything?
No, all study medicines, clinic visits, and trial-related tests are provided free of charge, and travel expenses are usually reimbursed.
Can I stop taking part if I change my mind?
Yes. Participation is entirely voluntary, and you can leave the trial at any point without giving a reason and without harming your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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