Study of WAL0921 in Patients With Glomerular Kidney Diseases
This study is looking into a new medicine called WAL0921 for adults aged 18 to 75 who have certain types of kidney disease. These include kidney problems related to diabetes, or rarer conditions like FSGS, minimal change disease, IgA nephropathy, and membranous nephropathy. The main goals are to find out if WAL0921 is safe, how well it works, and how the body uses it. Participants will receive the study medicine or a placebo (a dummy treatment) through a drip every two weeks for a total of seven times. After these treatments, everyone will be monitored for another 24 weeks to see how they are doing. This is a blind study, meaning neither you nor your doctor will know if you're getting the active medicine or the placebo.
At a glance
What is this study about?
This research study is focused on a new potential medicine, called WAL0921, for people living with specific kidney conditions. Your kidneys have tiny filters called glomeruli, and when these are damaged, it can lead to various kidney diseases. This study includes people with different types of these kidney conditions, such as kidney disease caused by diabetes, and some rarer forms like focal segmental glomerulosclerosis (FSGS), minimal change disease that hasn't responded to other treatments, IgA nephropathy, and membranous nephropathy.
The main purpose of this study is to carefully check if WAL0921 is safe to use and if it can help improve these kidney conditions. Researchers will also be looking at how the medicine works in your body. By taking part, you’d be helping doctors better understand these conditions and potentially find new ways to treat them.
It's important to know that this is a 'randomized' and 'double-blind' study. This means that participants will be randomly chosen to receive either the active medicine, WAL0921, or a placebo, which looks just like the study medicine but contains no active ingredients. Neither you nor your study doctor will know which you are receiving, which is a standard way to ensure the results are accurate and unbiased.
Key takeaways
- This study is testing a new medicine (WAL0921) for specific kidney conditions.
- It aims to check the safety and effectiveness of the new medicine.
- Participants will receive either the active medicine or a placebo (dummy treatment) through an IV drip.
- Neither you nor your doctor will know which treatment you are getting.
- The study involves regular visits, treatments for about 14 weeks, and a follow-up period of 24 weeks.
- You can choose to leave the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 75 years old. You must have one of the specific kidney conditions mentioned: diabetic nephropathy, focal segmental glomerulosclerosis (FSGS), minimal change disease that hasn't responded to previous treatments, IgA nephropathy, or membranous nephropathy. Your kidney function, as measured by a test called eGFR, also needs to be at a certain level – 30 mL/min/1.73 m2 or higher.
There are some reasons why you might not be able to join. For example, if you are pregnant or planning to become pregnant, or if you've ever had an organ transplant. You also can't participate if you've had issues with alcohol or substance use, or if you've needed urgent dialysis or had a sudden kidney injury in the last six months.
Finally, if your study doctor believes that another health condition you have might make it unsafe for you to take part, or prevent you from completing the study properly, then you wouldn't be able to join.
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?
- Do you have one of these kidney conditions: diabetic kidney disease, FSGS, minimal change disease (not responding to treatment), IgA nephropathy, or membranous nephropathy?
- Is your kidney function (eGFR) at 30 mL/min/1.73 m2 or higher?
- Are you not pregnant and not planning to become pregnant?
- Have you had an organ transplant, or recently had urgent dialysis or a sudden kidney injury (in the last 6 months)? (Answering 'yes' to this means you would likely not be eligible)
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, WAL0921, or the placebo through an intravenous (IV) drip into your arm. These infusions will happen once every two weeks, and you'll have a total of seven infusions. After your seventh and final infusion, the study team will continue to check on your health and kidney function for another 24 weeks. This follow-up period helps them understand the longer-term effects of the study medicine. Throughout the study, you'll have regular visits to the clinic for various tests and assessments, such as blood tests, urine tests, and general health checks. The total duration of your active participation, including the treatment and follow-up, will be about 38 weeks (approximately 9.5 months).
Potential risks and benefits
Locations (50)
- Academic Medical Research InstituteVerified postcodeLos Angeles, United States· Recruiting
- Colorado Kidney and Vascular CareVerified postcodeDenver, United States· Recruiting
- D & H Tamarac Research CenterVerified postcodeTamarac, United States· Recruiting
- Fides Clinical ResearchVerified postcodeAtlanta, United States· Recruiting
- Nephrology Associates of Northern Illinois and Indiana (NANI)Verified postcodeHinsdale, United States· Recruiting
- Dunes Clinical ResearchVerified postcodeDakota Dunes, United States· Recruiting
- Prolato Clinical Research CenterVerified postcodeHouston, United States· Recruiting
- Clinical Trial NetworkVerified postcodeHouston, United States· Recruiting
- Clinical Advancement CenterVerified postcodeSan Antonio, United States· Recruiting
- Westmead HospitalVerified postcodeWestmead, Australia· Recruiting
- Western Health Sunshine HospitalVerified postcodeSt Albans, Australia· Recruiting
- AIIMS HospitalVerified postcodeRaipur, India· Recruiting
Common questions
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving WAL0921 or the placebo.
How will the medicine be given?
The study medicine or placebo will be given to you through an intravenous (IV) drip into your arm.
How long will I be involved in the study?
You'll have treatments for about 14 weeks, followed by a monitoring period of 24 weeks. So, your total involvement will be approximately 38 weeks.
Can I leave the study at any time?
Yes, your participation is voluntary, and you can withdraw from the study at any time without needing to give a reason and without affecting your usual medical care.
How to find out more
Michelle Skupien
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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