A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy
IgA nephropathy is an autoimmune condition where a protein called IgA builds up inside the filters of your kidneys. This causes inflammation and can lead to kidney damage and protein leaking into your urine. This phase 2 trial is looking at an experimental medicine called ARGX-121. The treatment is given as an injection under the skin. Researchers want to find out whether ARGX-121 is safe, well-tolerated, and better than a dummy treatment (placebo) at lowering protein in the urine over 24 weeks. They will also track kidney function and blood markers over a full year (52 weeks). The study is open to adults aged 18 and older with primary IgA nephropathy. Taking part is completely voluntary, and participants are closely monitored by kidney specialists throughout the study.
At a glance
What is this study about?
Your kidneys contain tiny filters that clean your blood and remove waste through your urine. In IgA nephropathy, a type of antibody called Immunoglobulin A (IgA)—which normally helps fight infections—starts clumping together inside these filters. This causes inflammation and swelling. Over time, the filters become leaky, allowing protein and blood to slip into the urine. If left unchecked, this damage can slowly cause kidney function to decline.
This clinical study is evaluating a new potential treatment called ARGX-121. The drug is designed to target the underlying immune processes that drive this kidney damage. In this trial, researchers want to see if giving ARGX-121 as an injection under the skin can help calm the immune response, lower the amount of protein leaking into the urine, and keep the kidneys working well.
Because current treatment options for IgA nephropathy can be limited and do not always stop the condition from getting worse, finding new, targeted therapies is crucial. If ARGX-121 proves successful and safe, it could offer doctors a new way to help protect kidney function and reduce the risk of kidney failure in the future.
Key takeaways
- A phase 2 study testing a new injection (ARGX-121) for adults with IgA nephropathy.
- The primary goal is to see if it reduces protein leakage in the urine after 24 weeks.
- The study lasts for around 52 weeks to monitor long-term kidney function and overall safety.
- Participants are randomly assigned to receive either the study drug or a placebo injection.
- Taking part is completely voluntary and includes regular specialist health checks.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with primary IgA nephropathy. 'Primary' means the kidney problem is the main condition and is not caused by another illness, such as lupus or liver disease.
To see if you are a good match, the research team will check your kidney function and test your urine for protein levels. This usually involves doing a 24-hour urine collection to measure how much protein is being lost.
You may not be able to join if your kidney damage is already very advanced, if you have certain other serious medical conditions, or if you are taking specific medications that could interfere with the study results. The study team will run full health checks before you join.
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.
- You are aged 18 or older.
- You have a confirmed diagnosis of primary IgA nephropathy.
- You have protein showing up in your urine tests.
- You are willing to attend regular hospital appointments for around a year.
- You are comfortable having injections under the skin and completing 24-hour urine collections.
What does participation involve?
Taking part in this trial lasts for at least 52 weeks (one year). Participants will be randomly placed into one of two groups: one group receives the study drug (ARGX-121) and the other receives a matching dummy injection (placebo). Neither you nor your study doctor can choose which group you are in.
The medicine is given as a subcutaneous injection, which means a small needle is used to inject it under the skin. Throughout the year, you will need to attend regular clinic visits. At these visits, doctors will check your blood pressure, run heart traces (ECGs), collect blood samples, and ask you to collect urine over a 24-hour period. These tests help the team track how well your kidneys are filtering waste and watch closely for any side effects.
Potential risks and benefits
Locations (5)
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Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active drug. Comparing ARGX-121 to a placebo helps researchers prove whether any improvements or side effects are truly caused by the new medicine.
How is the study medicine given?
It is given as an injection just under the skin (subcutaneously), similar to how insulin or certain other routine medicines are injected.
Will I have to pay to take part?
No. Clinical trials in the UK do not charge participants for study medicines or tests. Many studies also help cover travel expenses to and from the hospital.
Can I keep taking my normal kidney medicines?
In most cases, participants continue their standard blood pressure or kidney protective tablets, provided the doses remain steady. Your trial doctor will review all your current prescriptions.
What happens if I change my mind?
You can leave the trial at any time, for any reason. You do not have to give an explanation, and your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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