Study of BHV-1400 in IgA Nephropathy
This research study is looking at a new medicine called BHV-1400, specifically for people who have a kidney disease called IgA Nephropathy, often shortened to IgAN. The main goal of this first stage of the study (called Phase 1) is to see if BHV-1400 is safe for people to take and if they can tolerate it well. Researchers will be carefully checking for any side effects. This study is open to both men and women between the ages of 18 and 65 who have a confirmed diagnosis of IgAN through a kidney biopsy. It's an important step in trying to find new ways to help manage this kidney condition.
At a glance
What is this study about?
This study is about a new medicine called BHV-1400, which is being investigated as a possible treatment for a kidney condition known as IgA Nephropathy, or IgAN for short. IgAN is a disease where a type of protein, called immunoglobulin A (IgA), builds up in the kidneys. This build-up can damage the kidneys over time and affect how well they work.
The main purpose of this particular study, which is in its early stages (called Phase 1), is to understand if BHV-1400 is safe for people to take and how well their bodies tolerate it. Before a new medicine can be tested to see if it works, doctors must first make sure it doesn't cause serious harm. This study will carefully monitor participants for any side effects or discomfort.
Finding new, safe treatments for IgAN is important because current treatments don't always stop the disease from getting worse for everyone. New medicines like BHV-1400 could potentially offer more options for people living with IgAN, helping to protect their kidney health in the long run. This early research is a vital step in developing better care for patients.
Key takeaways
- This study tests a new medicine (BHV-1400) for IgA Nephropathy.
- The main goal is to check its safety and how well people tolerate it.
- It's for adults with biopsy-confirmed IgAN, aged 18-65.
- You'll have regular hospital visits for check-ups and monitoring.
- Participation is voluntary, and you can withdraw anytime.
Who may be eligible?
This study is looking for adult volunteers who have a specific kidney disease called IgA Nephropathy (IgAN). To be considered, your diagnosis of IgAN must have been confirmed by a kidney biopsy, which is when doctors take a tiny sample of your kidney to examine it closely.
You must be between 18 and 65 years old to take part in this study. The study is open to both men and women.
However, some people won't be able to join. For example, if your IgAN is thought to be caused by another underlying health problem (this is called 'secondary IgAN'), you would not be eligible. Also, if you have any other type of long-term kidney disease that isn't IgAN, or if your kidney problems are due to other causes, you wouldn't be able to participate. This study specifically focuses on people with primary IgAN.
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 65 years old?
- Have you been diagnosed with IgA Nephropathy (IgAN)?
- Was your IgAN confirmed by a kidney biopsy?
- Do you have any other major type of chronic kidney disease?
- Is your IgAN 'primary' (meaning not caused by another specific illness)?
What does participation involve?
If you decide to take part in this study, you'll be given the new medicine, BHV-1400, likely in pill form. You'll have several visits to the study clinic where the medical team will keep a close eye on your health. During these visits, they might take blood and urine samples, check your blood pressure, and ask you how you're feeling and if you've noticed any changes. They'll be carefully monitoring for any side effects to make sure the medicine is safe. The full duration of your participation, including how many visits and how long you'll be taking the medicine, will be clearly explained to you before you agree to join.
Potential risks and benefits
Locations (15)
- Site-001Verified postcodeFarmington, United States· Recruiting
- Site-003Verified postcodeMiami Lakes, United States· Recruiting
- Site-011Verified postcodeMiami Lakes, United States· Recruiting
- Site-013Verified postcodeOrlando, United States· Recruiting
- Site-005Verified postcodePembroke Pines, United States· Recruiting
- Site-008Verified postcodeLawrenceville, United States· Recruiting
- Site-009Verified postcodeHinsdale, United States· Recruiting
- Site-012Verified postcodeIndianapolis, United States· Recruiting
- Site-015Verified postcodeShelby, United States· Not yet recruiting
- Site-006Verified postcodeChesterfield, United States· Recruiting
- Site-002Verified postcodeDakota Dunes, United States· Recruiting
- Site-014Verified postcodeHouston, United States· Recruiting
Common questions
What is IgA Nephropathy (IgAN)?
IgAN is a kidney disease where a protein called IgA builds up in your kidneys, which can damage them over time and affect how well they work.
What is BHV-1400?
BHV-1400 is a new medicine being tested in this study to see if it's safe for people with IgAN.
Why is this study being done?
The main reason is to find out if BHV-1400 is safe for people to take and if their bodies can tolerate it well, checking for any side effects.
Who can join this study?
Adults between 18 and 65 years old who have IgAN confirmed by a kidney biopsy are generally eligible.
Will I get 'cured' by taking part?
This early study focuses on safety, not on curing the disease. While there might be potential benefits, it's not guaranteed to improve your condition at this stage.
How to find out more
Chief Medical Officer
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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