The Ntrust-1 study
The Ntrust-1 study is part of a broad effort of the global research community to develop more treatment options for people living with lupus nephritis (LN) and primary membranous nephropathy (pMN).
Although current treatments can help manage symptoms, LN and pMN can cause damage to vital organs, including the kidney. More clinical studies are needed to find treatments that target the root of LN and pMN, which could potentially slow or stop its damaging effects. Do you want to help advance LN and pMN medical research? Consider enrolling in the Ntrust-1 study.
What is Ntrust-1 study?
The Ntrust-1 study is a clinical research study evaluating an investigational cell therapy, called NKX019, in adults living with lupus nephritis and primary membranous nephropathy.
What is NKX019?
NKX019 is an investigational cell therapy being studied for lupus nephritis (LN) and primary membranous nephropathy(pMN). It is designed to target and eliminate the cells that may trigger harmful antibodies, which attack the body’s own tissues in these conditions. Academic studies of a small number of autoimmune patients treated with other cell therapy products have indicated that if these cells can be eliminated, the harmful antibodies that attack the body’s own tissues in LN and pMN may also be eliminated. This could potentially slow or stop progression of the disease.
What is the purpose of this study?
As many as half of all adults living with lupus have kidney disease.1 LN can worsen over time and may lead to kidney failure.2 pMN is another autoimmune kidney disease that can also lead to progressive kidney damage. Studies like this are designed to assess the safety and activity of a new investigational therapy for both conditions.
The purpose of the Ntrust-1 study is to:
- Determine if NKX019 is safe to use and how well it is tolerated
- Determine if NKX019 can improve kidney function
- See if other medications like steroids can be stopped because LN or pMN is controlled
- See how the body processes NKX019 by measuring the NKX019 levels in the blood
Who can join this study?
You may be eligible to participate in this study if you:
- Are 18 to 70 years old
- Have been diagnosed with lupus nephritis or primary membranous nephropathy
- Have previously received at least 2 therapies for kidney issues
- Do NOT currently require renal (kidney) dialysis
You will also need to meet additional requirements. The study team will review these with you.
Compensation
If you are eligible and choose to participate, you will receive NKX019 and health assessments from a team with expertise in caring for people living with LN or pMN. Costs for travel, lodging, childcare, and meals will be covered when you and your care partner go to the study clinic. Compensation for study participants and your care partner may also be available.
Sources:
- https://www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis
- https://www.kidney.org/kidney-topics/lupus-nephritis