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Clinical Trials for IgAN and C3G: Are They Right for You?

It’s a way to further glomerular disease research and expand your treatment options

Scientists in white lab coats working in a lab, using microscope

If you have IgA nephropathy (IgAN) or complement 3 glomerulopathy (C3G), your provider may float the idea of joining a kidney disease clinical trial.

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The more you know about how these studies work, the easier it can be to decide if joining one is the right choice for you. Nephrologist Ali Mehdi, MD, shares what to expect from a clinical trial, how to find one that’s currently enrolling and what to consider before agreeing to participate.

Reasons to join a clinical trial

In addition to expanding your access to cutting-edge treatments, volunteering for a clinical trial also makes you a part of the global team that’s working to improve the health of people living with IgAN and C3G. Studies help us better understand how these kidney conditions work. And the more we know, the better the treatment options become.

Before a medication makes it to your pharmacy, it goes through several clinical trial phases, testing it for safety and effectiveness. The results of those clinical trials help regulators in the U.S. and around the world decide whether to approve a therapy for public use.

Participating in a kidney disease clinical trial doesn’t just give you access to treatments that aren’t yet widely available. It also helps pave the way for the best of those drugs to make it to other people who need them.

What are clinical trials like?

All clinical trials follow strict rules and protocols — but what that actually means for you depends on the clinical trial type and phase. Still, there are some basics that are always true.

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Clinical trials have four phases. But to even get to phase one, the treatment has to undergo extensive preclinical research. These are usually laboratory or “bench” studies. For a treatment to be tested on people, those bench studies have to show strong evidence that it’s safe and likely to work.

Most clinical trials are randomized and double-blinded. That means neither you nor the researcher knows if you’re getting the treatment that’s being studied. You could be receiving a placebo instead.

A placebo is a fake treatment — think sugar pills instead of the actual drug, or a saline and water injection instead of a vaccine. Researchers use placebos to compare the outcome of treatments against non-treatment options and prevent the researcher’s thoughts or feelings from affecting the study results.

To be clear: Getting a placebo doesn’t mean your IgAN or C3G will be allowed to progress unchecked.

Some clinical trials allow you to stay on your current treatment regimen throughout, while others require changing or stopping your medications. You’ll only be recommended for trials that affect your treatment plan if:

  • The therapies you’re on aren’t working
  • Your provider feels your condition is stable enough to participate safely

Either way, you’re not going to be dealing with your kidney disease alone.

“You’ll still get the high-quality care you’d receive if you weren’t in a study,” Dr. Mehdi explains. “Otherwise, the clinical trial would be unethical.”

You’ll have appointments with both the research team and your nephrologist throughout the course of the study. It doesn’t matter if you’re in the treatment group or the placebo group.

“If your provider or the researchers notice that your kidney function is worsening, they can remove you from the trial and move you on to something else,” he adds.

Regardless of what group you’re in or how the study turns out, this much is true: Taking part in a kidney disease clinical trial helps push IgAN and C3G science forward.

How to find a clinical trial

One of the reasons it’s important to have a nephrologist you trust is that they’re the best resource for getting connected to clinical trials. They can refer you directly to the research team working on the study. They may even know the researchers personally.

But if you’re curious, you can also search clinicaltrials.gov to see clinical trials that are in the recruitment phase.

At any given time, there are usually plenty of studies running — even for conditions like IgAN and C3G — that everyday people may not know about.

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“Within nephrology, we have many clinical trials open,” Dr. Mehdi says. “These studies address the core of these diseases, at the cellular and biochemical level. They’re the reason we can offer more effective and safer treatment options now than we could five or 10 years ago.”

Risks of joining a clinical trial

If there are any risks involved in participating in a clinical trial, the researchers have to tell you about them before you sign the consent form. This principle is called “informed consent.” If you don’t understand what the researchers are telling you or have any doubts, speak to your provider.

In the U.S., before conducting a clinical trial, researchers have their study approved by a committee registered with the U.S. Food and Drug Administration (FDA) called an institutional review board (IRB). This helps ensure the risks involved are reasonable — and that the researchers run the study ethically. Common risks include:

  • Disease progression: Depending on the type and phase of the clinical trial you’re in, you may change or stop the medications you’re currently on. While every measure is taken to prevent your condition from getting worse as a result, it could still happen.
  • Receiving a placebo: Most people join trials hoping to receive an experimental IgAN or C3G treatment, not a placebo. But if you’re in the placebo group for a treatment that works, you may receive it at a discounted rate following FDA approval.
  • The treatment not working: In science, learning that an experimental treatment doesn’t work is just as important as learning that it does. But it can still be discouraging.
  • Adverse events: An adverse event is a negative change in your health that happens during a clinical trial. It can be mild, moderate or severe — and may not have anything to do with the experimental therapy you’re getting. You’ll receive medical care for any health issue you have. If the problem is serious, the investigators are legally required to report it. And if regulators decide a study is too dangerous to the participants, it gets suspended.

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All clinical trials involve some risk. Whether it’s a risk worth taking is something you’ll need to decide for yourself. But you can always turn to your nephrologist with questions and concerns. They’ll respect and support your wishes, whatever they are.

Final thoughts

While choosing to join a clinical trial for IgAN or C3G may feel like a huge decision, it’s important to remember: You’re not locked into anything. If your situation changes, so can your choice.

“The thing about consenting to a clinical trial is that you can take that consent away whenever you want,” Dr. Mehdi reassures. “If you’re participating, it’s always because you want to do it.”

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