A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
This study is about a kidney condition called Primary Membranous Nephropathy (PMN). In PMN, your body's immune system mistakenly attacks your kidneys, causing damage and leading to protein leaking into your urine. This can make you feel tired and cause swelling. This research compares a new study drug, felzartamab, with a standard treatment called tacrolimus. Felzartamab works by targeting the cells that cause the kidney damage. The main goal is to see which treatment best helps bring down protein levels in the urine and keeps kidneys working well. Researchers will also check for side effects and how the drugs affect your overall health.
At a glance
What is this study about?
This study is for adults who have a kidney condition called Primary Membranous Nephropathy, or PMN. Normally, your kidneys have tiny filters called glomeruli that clean your blood and remove waste. In PMN, your immune system – which usually fights off germs – gets confused and creates special proteins called autoantibodies. These autoantibodies attack and damage the kidney filters. When these filters are damaged, too much protein and sometimes blood can leak into your urine. This can cause symptoms like swelling in your legs, feeling very tired, and high blood pressure. If not treated, PMN can unfortunately lead to serious kidney problems over time.
Researchers want to learn more about a new study drug called felzartamab. This drug is a 'monoclonal antibody,' which is a special type of protein made in a lab. It's designed to target and reduce the immune cells that produce those harmful autoantibodies, hopefully preventing further damage to your kidneys. The main purpose of this study is to compare how well felzartamab works against another common treatment for PMN called tacrolimus, which is already used to help people with this condition. They want to find out which treatment is better at bringing down the high levels of protein in your urine and keeping your kidneys healthy.
The main question they're trying to answer is how many people achieve a 'complete response' after about two years of treatment. A complete response means your urine protein levels become very low and your kidney function stays stable. They will also look at how quickly your disease might get worse, how long your urine protein levels stay low, if you develop antibodies against the study drug, how the drug moves through your body, and if it helps with tiredness and overall well-being. This information will help doctors understand if felzartamab could be a good new option for treating PMN.
Key takeaways
- This study is testing a new drug, felzartamab, for a kidney disease called PMN.
- It compares felzartamab with an existing treatment, tacrolimus.
- The main goal is to see which drug best reduces protein in urine and protects kidneys.
- Participation involves regular visits, blood tests, and either injections or tablets.
- The study could last up to two or three years, depending on your treatment.
Who may be eligible?
To join this study, you generally need to be an adult between 18 and 80 years old who has been diagnosed with Primary Membranous Nephropathy (PMN). Importantly, a doctor must have decided that you need treatment for your PMN. This diagnosis usually needs to be confirmed by a kidney biopsy, which is a small sample taken from your kidney, either recently or within the last five years.
There might be a special exception if you have certain 'anti-PLA2R antibodies' in your blood. If these antibodies are present and your doctor confirms there's no other clear reason for your kidney problems, you might not need a recent biopsy to join. Also, you must either be newly diagnosed with PMN and never had specific treatment for it before, or your PMN has come back after you previously got better with treatment.
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.
- Are you an adult between 18 and 80 years old?
- Have you been diagnosed with Primary Membranous Nephropathy (PMN)?
- Has your doctor said you need treatment for your PMN?
- Have you either been newly diagnosed or has your PMN returned after previous treatment?
- Do you have a kidney biopsy report, or special anti-PLA2R antibodies?
What does participation involve?
If you decide to take part, you'll first have a screening period of up to 42 days to check if the study is right for you. If you qualify, you'll be randomly assigned to receive either felzartamab (given through a drip into your arm) or tacrolimus (taken as tablets). You won't get to choose which treatment you receive. During the study, you'll have regular visits – up to 23 visits in total. These visits will involve various tests to monitor your kidney health and how you're feeling.
The main treatment period could last up to 104 weeks (about two years). If at any point your kidney function gets worse or your PMN doesn’t improve, there's a chance you might receive a different 'rescue treatment.' If you need this, you would stay in the study for a longer period, up to 156 weeks (about three years). Even if you stop your assigned treatment early, you'll still have follow-up visits every 12 weeks until the 104-week mark to keep an eye on your health.
Potential risks and benefits
Locations (100)
- Apogee Clinical Research, LLCVerified postcodeHuntsville, United States· Recruiting
- The Nephrology Group, Inc. - FresnoVerified postcodeFresno, United States· Recruiting
- Academic Medical Research InstituteVerified postcodeLos Angeles, United States· Recruiting
- UCSF Medical CenterVerified postcodeSan Francisco, United States· Recruiting
- Stanford UniversityVerified postcodeStanford, United States· Recruiting
- Henry Ford Hospital- A-Basement Research PharmacyVerified postcodeDetroit, United States· Recruiting
- Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDSVerified postcodePontiac, United States· Completed
- James J Peters Veterans Administration Medical Center - NAVREF - PPDSVerified postcodeThe Bronx, United States· Recruiting
- ECU Physicians Nephrology and HypertensionVerified postcodeGreenville, United States· Recruiting
- University Hospitals Cleveland Medical CenterVerified postcodeCleveland, United States· Recruiting
- Knoxville Kidney Center, PLLCVerified postcodeKnoxville, United States· Recruiting
- Vanderbilt University Medical CenterVerified postcodeNashville, United States· Recruiting
Common questions
What is Primary Membranous Nephropathy (PMN)?
It's a kidney disease where your body's immune system mistakenly attacks your kidney filters, causing protein to leak into your urine.
What is felzartamab?
It's a new study drug, a special type of protein made in a lab, designed to target and reduce the cells causing kidney damage in PMN.
Why is this study important?
It aims to find out if felzartamab is a better or safer treatment for PMN compared to current options, which could help many people with this condition.
Will I know which treatment I'm getting?
No, you'll be randomly assigned to either felzartamab or tacrolimus, and you won't know which one you are receiving.
What happens if my kidneys get worse during the study?
If your kidney health declines, you might be offered a 'rescue treatment' and continue to be monitored within the study.
How to find out more
US Biogen Clinical Trial Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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