Clinical trials for kidney disease and other kidney diseases
- Medically reviewed by
- AKF's Medical Advisory Committee
- Last updated
- January 20, 2023
Clinical trials are key to advancing the treatment of chronic kidney disease and other types of kidney diseases, such as polycystic kidney disease (PKD), glomerulonephritis, IgA nephropathy (IgAN), lupus nephritis, rare kidney diseases, and others. Learn about how clinical trials work and see if you match.
What are clinical trials?
Clinical trials are research studies that study the effectiveness of new treatments.
It takes an average of 12 years for a prescription drug to make it from the beginning – an experiment in a laboratory – to its final destination, your pharmacy shelf? Before a new medicine, therapy, or method of preventing or diagnosing a disease can be approved for human use, it first must be tested by researchers for many years. The product is tested in a laboratory, and eventually makes its way to being tested in humans during clinical trials.
As you research clinical trials, you may hear the terms placebo, bias, single-blind (masked) study or double-blind (masked) study. Learn about important clinical trial terminology.
Are Clinical Trials Safe?
Many safeguards are put in place to protect the people who participate in clinical trials. These safeguards are meant to protect participants from possible harmful side effects of the treatments being tested, as well as to protect participants from being treated unfairly during the research study.
Some of the protections happen before the clinical trial starts, and some happen during the clinical trial.
Learn about the safeguards that are used to protect patients.
What are the advantages and Disadvantages of participating in clinical trials
Possible benefits to participants:
- Gain access to new and possibly effective treatments or medicine available only to those participating in the trial
- Gain focused health care for a particular disease or health condition
- Learn more about your disease or health condition
- Have the chance to help society and other people with your disease or health condition by contributing to medical research
- Getting paid, in some cases
Possible disadvantages to participants:
- You may have more health visits than you would have with your regular personal doctor
- You may spend more money than usual for traveling for the visits, special medicines and medical tests that are not covered by your health insurance
- The study treatment or medicine may not make you feel better
- In rare cases, there may be negative, or serious side effects from the study treatments and/or medicines
Benefits to science and future health care:
- Contribute to the development of new medicines and treatment guidelines
- Contribute to the discovery of ways to prevent or cure diseases or health conditions
- Improve the way doctors, nurses and other health professionals are trained
- Influence health laws and funding for health services
What are the phases of clinical trials?
There are usually four phases of a clinical trial. Each phase helps move the study along, step by step. The purpose of a clinical trial could be to study a medicine, a therapy, or a method of preventing or detecting a disease.
- Phase 1: Small trial of 20-100 people why researchers observe the participants very closely, and check to see how the medicine or therapy works in a human body
- Phase 2: Larger trial of about 300 people to gather more information about how safe the medicine or therapy is.
- Phase 3: Includes 300 - 3,000 people who have the disease to check whether the medicine or therapy actually works to prevent, diagnose or treat the disease or health condition it was made for.
- Phase 4: After the FDA approaches the drug, this phase follows thousands of people who have the disease to look at the new medicine or therapy's benefits and risks (side effects) and at the way to best use it.
What are the types of clinical trials?
- Treatment trials test new medicines, treatments or therapies for a disease or health condition.
- Prevention trials look for new and improved ways to prevent a disease or a health condition. Prevention trials may involve testing out medicines, vitamins, vaccines or lifestyle changes.
- Diagnostic or screening trials study the best ways to diagnose or detect a disease or health condition.
- Quality of life trials study how the side effects of a treatment (like dialysis) affect the patient's well-being and daily functions.
- Genetic trials look at how genes (DNA) are related to certain diseases or health conditions.
- Epidemiological (ep′i·de′mi·o·log′i·cal) trials look for patterns of certain diseases or health conditions across groups of people (for example: people of certain races/ethnicities may have a disease more often than others).
Match to a clinical trial
The American Kidney Fund has partnered with Antidote Match to help make it easier to find clinical trials that may be of interest to you or your family. Use the search box below to get started!
Who pays for my health care during a clinical trial?
It is important to know that because you join a clinical trial, the health services you get during the study are not always free. If you have health insurance, (including private insurance, and government insurance, like Medicare and Medicaid), the costs for routine services and testing that you normally get at your regular personal doctor may not be covered.
Before you agree to join the trial, ask the treatment team what specific health services, testing and medical treatment are free (whether you have insurance or not). The study team will go through informed consent with you, which will include which costs are and are not covered. Ask your health insurance company what costs they will and will not cover related to being part of the clinical trial.
Non-medical expenses related to clinical trials
There are some clinical trials that will pay for your meals and travel costs to the medical facility where the study is being done (especially if you have to travel far away from your home). If you and your family have to travel out of state and will be at the study location for many days, they may pay for your housing. Ask about these costs before you agree to join the trial.
Who can be part of a clinical trial?
At the beginning of a clinical trial, the researchers, also known as the treatment team, look for people who qualify to participate in the study. The qualifications needed to participate in a clinical trial, known as eligibility criteria, depend on what the researchers are going to study. Often researchers decide who qualifies to participate in a clinical trial based on:
- Having the disease or health condition being studied (patient volunteers)
- Not having the disease or health condition being studied (healthy volunteers)
For example, if researchers want to find out how well a new drug for diabetes works on elderly people, they might search for people who are diabetic, and older than 75 years, to volunteer for their clinical trial. Before you say "yes" to join a clinical trial, you should talk to your personal doctor about how the study may improve or worsen your current health condition. Also, you should talk to the researchers about the possible benefits and risks to your health from the clinical trial. You always have the right to leave the clinical trial at any time and for any reason.
What happens during and after a clinical trial?
During a clinical trial
During the clinical trial, your treatment team may include doctors, nurses, social workers and other health providers who will provide your healthcare. They will do the tests and exams related to the study. They will usually share your results and provide other information to your personal doctor(s) if you allow.
You may be asked to do tasks at home so that they can keep track of how you are doing. For example, you may be asked to write down what foods you eat each day. To make sure the final results of the clinical trial are accurate, everyone in the study must do all the tasks the treatment team asks. These can include: coming to your visits, taking all medicines given and doing all the home tasks correctly.
After a clinical trial
What happens after the clinical trial is over depends on the type of study it was. In general, when the clinical trial is over, the treatment team will look at the results together from everyone in the trial. If it was a clinical trial for a new medicine and the results showed that the medicine worked, the trial will continue to the next clinical trial phase. In most cases, when the trial ends, the people in the study are no longer needed. In the next phase, a new group of people are selected.
At the end of the trial, you usually do not get your individual results. But the summary of everyone's results are included together in a published report or article you can get online, from a library or from the treatment team.
Diversity in clinical trials
Clinical trial participants are key to developing safe treatments that work well to prevent, diagnose and treat kidney disease. The participants in clinical trials should represent the diverse group of people who have the health problem being studied and will use the treatment out in the world. However, Black, Hispanic, Native American and Asian American people are often underrepresented in clinical trials. This means that compared to the number of people from these communities who are living with kidney disease, few participate in clinical trials.
Learn more about why diversity in clinical trials is important and consider why you should take part in a clinical trial.
Learn why your participation makes a difference.
What questions should I ask the treatment team?
Anyone interested in joining in a clinical study should know as much as possible about the study and feel comfortable asking the treatment team questions about the study. If you or your family members have different questions, write them down and ask the treatment team.
Answers to some of your questions may be answered in the Informed Consent document.
- Why is this clinical trial being done?
- What information are you (the treatment team) trying to get from this study?
- What are the possible risks and side effects from being in the trial?
- What are the possible benefits of treatment?
- How long will I be in the study?
- What happens if I get sicker while I am in the study?