A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis
This research study is investigating a new medication, Zetomipzomib (KZR-616), for individuals who have lupus that is affecting their kidneys, known as lupus nephritis. The main goal is to find out if this new drug, given at two different dose levels (30 mg or 60 mg), is effective and safe when compared to a dummy treatment (placebo). Participants will also be receiving standard treatments for their condition. The study aims to see how many patients show significant improvement in their kidney health after a certain period. This type of study, called a Phase 2b trial, helps researchers understand more about how the new medicine works and if it has the potential to become a new treatment option in the future.
At a glance
What is this study about?
You've been invited to learn about a research study for people with lupus nephritis. This is a condition where lupus, an autoimmune disease, attacks the kidneys, which can cause serious health problems. The aim of this study is to test a new medication called Zetomipzomib (KZR-616). Researchers want to see if this new drug can help improve kidney function and reduce the symptoms of lupus nephritis while also being safe to use.
In this study, some people will receive the new medication at one of two different doses, while others will receive a placebo. A placebo looks like the real medicine but contains no active drug. This is a common way to test new treatments fairly, as neither you nor your doctors will know whether you're receiving the new medicine or the placebo. Everyone in the study will also receive other standard treatments for lupus nephritis, such as methylprednisolone, which is a type of steroid.
The main thing researchers will look at is how many patients achieve a significant improvement in their kidney health after about 37 weeks. They will also look at other measures of kidney improvement over different time periods, how the drug affects overall lupus activity, and how it impacts your quality of life. The information gathered from this study will help doctors understand if Zetomipzomib (KZR-616) could be a helpful new treatment for people living with lupus nephritis.
Key takeaways
- This study tests a new medicine for lupus affecting the kidneys.
- It compares the new drug to a dummy treatment (placebo).
- You'll also receive standard care for lupus nephritis.
- The study aims to see if the drug improves kidney health and is safe.
- Participation involves regular clinic visits and tests.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part.
The most important thing is that you have active lupus nephritis. This means your lupus is currently affecting your kidneys and causing problems. The study doctors will perform tests to confirm that your condition meets the specific requirements needed for the study.
There might be other health conditions or medications that would prevent you from joining, as the researchers need to ensure the study is safe and effective for everyone involved. Your doctor and the study team will go through all the details with you to see if this study is a good fit.
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 18 years old or older?
- Do you have lupus that is currently affecting your kidneys (active lupus nephritis)?
- Are you able to attend regular clinic visits and appointments?
- Are you willing to potentially receive a placebo?
- Are you comfortable with blood and urine tests, and potentially other medical procedures?
What does participation involve?
If you decide to participate, you'll be assigned to one of three groups by chance, like flipping a coin. You'll either receive the new study medicine at a lower dose, the new medicine at a higher dose, or a placebo (which contains no active drug). You and your study doctors won't know which group you are in, and everyone will also receive standard care treatments for lupus nephritis.
Taking part will involve regular visits to the study clinic over several months. These visits will include various tests such as blood and urine samples, possibly kidney biopsies, and physical examinations to closely monitor your health and how your kidneys are responding. You'll also be asked to complete questionnaires about your general health and how you feel, which helps researchers understand your quality of life.
The study will last for a total of 53 weeks (just over a year). After this period, there will likely be follow-up appointments to continue monitoring your health and any effects of the treatment.
Potential risks and benefits
Locations (7)
- —UnverifiedPortugal
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedCroatia
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is lupus nephritis?
Lupus nephritis is a kidney disease caused by lupus, where your immune system mistakenly attacks your kidneys, making them not work as well as they should.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.
How long will the study last?
The main part of the study where you're receiving treatment and being monitored will last for 53 weeks (just over a year).
Will I still receive my usual lupus treatment?
Yes, everyone in the study will also receive other standard treatments for lupus nephritis, such as methylprednisolone, along with the study drug or placebo.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect the medical care you receive for your lupus.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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