Clinical trials are a way to test whether a new drug, device, or another type of treatment is safe for use in humans if it has any side effects if it works better than other treatments, and if it helps improve the quality of life. While there is still no cure for IgA Nephropathy, the FDA recently approved the first drug for IgA Nephropathy based on the results of a clinical trial that found it can reduce urine protein in IgA Nephropathy in some patients.
Who can take part
If you are considering enrolling in a clinical trial, talk with your care team.
Clinical trials are designed so that participants who are included in the study are similar. This helps to ensure that the results are due to what is being studied and not to other factors or chance alone. To accomplish this, each study will outline factors that allow or prevent someone from participating (called inclusion and exclusion criteria).
So in order to join a specific study, you must meet certain requirements.
Criteria may relate to
- Stage of kidney disease
- Recent labs, for example, how much protein is in the urine, GFR levels
- Medical history and/or previous treatments someone has tried
- Current health status, fitness, and/or functional level
- Other health conditions
- Time since last treatment
There can be some key benefits and possible risks to participating in a clinical trial.
Clinical trials aim to show whether a new treatment or procedure:
- Is safe
- Has side effects
- Works better than or just as well as currently available treatments
- Improves your quality of life and how you feel on a day-to-day basis
- Improves other outcomes (slows progression of kidney declines, reduces protein in the urine, improves GFR levels. etc.)
- Closer monitoring, with more frequent check-ups, lab work, and other tests
- Access to treatment that is only available as part of the trial and could be better than currently available treatments or make them more effective
- A chance to help improve treatment – and work toward a potential cure for IgA Nephropathy for patients in the future – by helping researchers gather data and better understand the disease
- You may get a placebo (no treatment), instead of the study therapy; the investigational drug and placebo are usually added to standard medical care
- You may experience new side effects, even though the treatment has been carefully studied in a lab before it moves to clinical trials
- You may not respond to the new treatment
- In some cases, health insurance may not cover it
- You might need to travel and study-related appointments or additional follow-up can take more of your time.
While not all clinical studies result in new treatments (for example, the study drug may not be found to work, or perhaps it has too many side effects when compared with existing treatments), this research invariably adds to our knowledge about IgA Nephropathy and helps build a comprehensive understanding of how to treat it. Amassing as much information as possible helps improve care overall, and having willing clinical trial participants is crucial to the process.
Getting your (informed) consent – a key first step
If you qualify for a study, one of the first things you will do is meet with the research team. They will go over the study in detail. They will also want to get written permission from you that you understand and are OK with participating in the study.
You will be given information about:
- The purpose of the study – what the researchers are hoping to test or find out
- Who is eligible to take part
- What is currently known about the treatment or intervention
- Possible side effects or benefits expected
- How it is decided which study group or treatment you will be in or receive?
- How the study will be conducted and if you will know what treatment you are getting or if that information will be kept from you until the end of the study (this is called blinded); often clinical studies are done by randomly assigning participants to one of two study groups (like drawing names out of a hat), so you won’t necessarily have a choice.
- What are the expected costs?
- How will information about me be kept private?
- Your rights and how information about you is protected and that you are able to leave the trial at any time
Question to ask
Remember, it is always your choice to join a clinical trial. So take the time you need to learn about the study and ask questions.
- What are the risks? What do we already know about the drug or other treatment being tested?
- How might the study drug improve how I feel and/or my kidney function now and over time?
- Will I know if I am receiving the study drug or placebo (an inactive treatment)?
- What phase (or stage) is the clinical trial in (studies are conducted in phases that build on one another to answer certain questions). A study may be in Phase 1, 2 or 3 or even to monitor treatment after it is more widely available to track any long-term data on outcomes or side effects.
- Will I need to plan on extra time or travel?
- Will my insurance cover the treatment?
- How does the study team coordinate with my other doctors?
- Who should I call if I have questions or concerns once the study starts?
- If the treatment works well for me – or people who are in the treatment group – can I keep taking it or ask to start it after the trial ends?
If you are thinking about enrolling in a clinical trial, we have a full list of studies looking at new treatments for IgA Nephropathy on our Clinical Trials page