This study focuses on IgA Nephropathy, a kidney disease where abnormal antibodies build up in the kidneys. The main treatment being tested is Felzartamab, which is given through intravenous administration. The study will compare this medication against a placebo to see how well it works in reducing protein in the urine of adult patients with this condition.
Several supportive medications may be used during the study, including Desloratadine, Diphenhydramine, Cetirizine, Fexofenadine, Paracetamol, Methylprednisolone, Levocetirizine, Loratadine, and Famotidine. These medications are used to manage potential side effects or symptoms that participants might experience during the treatment. A Saline solution will also be used as part of the treatment process.
The purpose of this research is to evaluate how effective Felzartamab is compared to placebo in reducing the amount of protein in the urine of people with IgA Nephropathy. The study will last several years, during which participants will receive regular infusions of either Felzartamab or placebo, and their kidney function will be monitored through various tests.
1Initial Treatment Phase
You will receive either felzartamab or placebo through intravenous administration (into a vein).
During treatment, you must continue taking your current kidney medications at stable doses, including ACE inhibitors or ARB medications.
Your protein levels in urine and kidney function will be regularly monitored through urine and blood tests.
2Pre-medication Protocol
Before each felzartamab infusion, you will receive medications to prevent possible reactions:
– Antihistamines (such as diphenhydramine, cetirizine, or desloratadine)
– Paracetamol
– Methylprednisolone
3Monitoring Phase
Regular checks will measure:
– Changes in protein levels in your urine
– Kidney function through blood tests
– Physical examination and vital signs
– Heart activity through ECG testing
– Presence of antibodies against the study medication
4Long-term Follow-up
The study continues until June 2029
Your kidney function will be monitored for signs of improvement or decline
Any side effects or health changes will be documented and assessed
Who Can Join the Study?
Must have IgA nephropathy confirmed by kidney biopsy within the last 10 years. For patients with type 2 diabetes, the biopsy must be from the last 24 months
Must have adequate kidney function measured by eGFR (a blood test that shows how well your kidneys are working):
– At least 30 mL/min/1.73m² for most patients
– Between 20-30 mL/min/1.73m² may be accepted for specific study groups
Must be on a stable dose of blood pressure medications (ACE inhibitors or ARBs) for at least 12 weeks, or have documented intolerance to these medications
May be taking other medications for kidney disease (SGLT2 inhibitors, endothelin receptor blockers, or mineralocorticoid receptor blockers) if the dose has been stable for at least 12 weeks
Must have significant protein in urine, shown by either:
– At least 1.0 gram of protein in a 24-hour urine collection, or
– A urine protein-to-creatinine ratio of at least 0.8 grams per gram
Both men and women can participate
Must be an adult (18 years or older)
If taking a medication called sparsentan, cannot be taking ACE inhibitors or ARBs at the same time
Who Cannot Join the Study?
History of organ transplant or current plans for kidney transplant
Active hepatitis B or C infection (viral infections affecting the liver)
Known HIV infection
Current diagnosis of cancer or cancer treatment in the past 5 years
Other types of kidney diseases besides IgA nephropathy
History of severe allergic reactions to medications
Pregnancy or breastfeeding
Participation in other clinical trials within the past 30 days
Severe heart disease or uncontrolled high blood pressure
Serious infections requiring hospitalization within the past 3 months
Use of certain medications that affect the immune system
Alcohol or drug abuse within the past year
Any condition that, in the opinion of the study doctor, would make participation unsafe
Felzartamab is an investigational medication being studied for the treatment of IgA nephropathy, which is a kidney disease. It works by targeting and reducing specific antibodies in the body that contribute to kidney inflammation and damage. This medication is given to patients alongside their standard treatments to help reduce the amount of protein in their urine, which is a sign of kidney disease severity.
Placebo is an inactive substance that contains no medication. It is used as a comparison to help determine if felzartamab is effective in treating IgA nephropathy.
IgA Nephropathy – A kidney disease where an antibody called immunoglobulin A (IgA) builds up in the kidneys. The disease occurs when IgA deposits in the kidneys, causing inflammation that can interfere with the kidneys’ ability to filter waste from blood. It develops gradually over many years and primarily affects the kidney’s filtering units called glomeruli. The condition often starts during the teenage years or early adulthood. Over time, it can cause protein and blood to leak into the urine, leading to changes in urination patterns and visible blood in urine. The disease progresses differently in each person, with some experiencing very slow progression while others notice more rapid changes in kidney function.
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