A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
This study is exploring a new medicine called felzartamab for adults aged 18-75 with lupus nephritis (LN). LN happens when the body's immune system mistakenly attacks the kidneys, causing inflammation and damage. Felzartamab is a laboratory-made antibody designed to target specific immune cells that contribute to this kidney damage. The main goal is to find out if felzartamab is safe and how it affects the kidneys when taken alongside current standard treatments for LN. Researchers will also look at how it might improve kidney function and reduce protein in the urine. This information will help decide if more research should be done on felzartamab as a potential new treatment for LN.
At a glance
What is this study about?
This study is all about understanding a new potential medicine, called felzartamab, for people who have a condition called lupus nephritis, often shortened to LN. Lupus is a disease where your body's defence system, called the immune system, mistakenly attacks its own healthy tissues. When it attacks the kidneys, it's called lupus nephritis.
In LN, tiny filters in your kidneys, called glomeruli, get damaged by certain proteins from your immune system. This damage can make your kidneys leak important proteins and even blood into your urine, which isn't normal. You might also experience swelling, fever, or high blood pressure. If this kidney damage isn't properly managed, it can sadly lead to serious kidney problems.
Felzartamab is a special type of medicine created in a lab. It's designed to target specific immune cells that cause this kidney damage in LN. By doing this, researchers hope it might help reduce the inflammation and damage in the kidneys. The main thing they want to learn from this study is whether felzartamab is safe to use and how it acts in the body of people with LN who are also receiving their usual treatments. This early research will help doctors decide if felzartamab could be a helpful new treatment in the future.
Key takeaways
- This study explores a new medicine, felzartamab, for active lupus nephritis.
- It aims to understand the safety and effects of felzartamab when combined with usual treatments.
- Felzartamab targets immune cells thought to cause kidney damage in LN.
- Participation involves regular visits and receiving the medicine via an IV drip over about 2 years.
- Eligible participants are adults aged 18-75 with confirmed, active lupus nephritis.
- All participants will continue their current standard lupus nephritis medications.
Who may be eligible?
To join this study, you generally need to be an adult between 18 and 75 years old and have a confirmed diagnosis of lupus nephritis (LN) that's currently active. You also need to have tried at least one standard LN treatment for at least three months, but either it didn't work well enough, or you couldn't tolerate it.
There are also some specific requirements about your kidney health. For example, your kidney biopsy (a small sample of kidney tissue) needs to show a certain type of LN, and it must have been done within a specific timeframe. Your kidney function, measured by special blood and urine tests, also needs to be at a certain level. If you have very rapidly worsening kidney disease or too much scarring in your kidneys, this study might not be 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.
- Are you between 18 and 75 years old?
- Have you been diagnosed with lupus nephritis that is currently active?
- Have you tried at least one standard treatment for lupus nephritis for at least 3 months, which either didn't work well or you couldn't tolerate?
- Does your recent kidney biopsy (done within the last year, or 6 months if your kidney function is lower) confirm a specific type of lupus nephritis?
- Is your kidney function currently at a certain level based on specific tests?
- Do you NOT have rapidly worsening kidney disease or too much scarring in your kidneys?
What does participation involve?
If you join, the study will last about 2 years. First, there's a screening period of up to 42 days to check if you're suitable. Throughout the entire study, you will continue your usual lupus nephritis treatments as prescribed by your doctor. The study medicine, felzartamab, will be given through a drip into a vein (this is called an IV infusion).
There are two parts to the study. In Part 1, you can expect up to 14 visits to the study centre. If you go on to Part 2, you might have up to 15 visits. During these visits, researchers will monitor your health, take blood and urine samples, and check how well the treatment is working.
Potential risks and benefits
Locations (24)
- University of California, San Diego (UCSD)Verified postcodeLa Jolla, United States
- University of California, San Francisco (UCSF)Verified postcodeSan Francisco, United States
- Stanford University Medical CenterVerified postcodeStanford, United States
- ClinCept, LLC/River City Vascular Specialists LLCVerified postcodeColumbus, United States
- Georgia Nephrology - LawrencevilleVerified postcodeLawrenceville, United States
- University of MichiganVerified postcodeAnn Arbor, United States
- Joseph S. and Diane H. Steinberg Ambulatory Care CenterVerified postcodeBrooklyn, United States
- SUNY Downstate Medical CenterVerified postcodeBrooklyn, United States
- University Hospitals Cleveland Medical CenterVerified postcodeCleveland, United States
- The Ohio State University (OSU)Verified postcodeColumbus, United States
- Precision Comprehensive Clinical Research Solutions - GrapevineVerified postcodeGrapevine, United States
- Prolato Clinical Research CenterVerified postcodeHouston, United States
Common questions
What is lupus nephritis?
Lupus nephritis is a kidney condition that happens when lupus, an immune system disease, causes inflammation and damage to your kidneys.
What is felzartamab?
Felzartamab is a new investigational medicine, created in a lab, that aims to reduce kidney damage by targeting specific immune cells in people with lupus nephritis.
What is 'standard of care'?
Standard of care refers to the usual treatments and medical attention you would typically receive from your doctor for your lupus nephritis.
How will I know if the treatment is working?
The researchers will look at things like protein levels in your urine, kidney function tests, and other blood tests related to lupus to see how the study medicine affects your condition.
How will the medicine be given?
The study medicine, felzartamab, will be given directly into your vein through a drip, which is called an intravenous (IV) infusion.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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