In Partnership with CSL Behring

If you are new to clinical trial research participation but are interested in learning more, the first step is to let your transplant team know that you would like more information about clinical trials. Your doctor is your primary source of information about which trials are available at your transplant center and for which you may be eligible. It’s important for you to ask your healthcare team questions to better understand whether clinical trial participation might be a good option for you.

Types of Available Trials

There is an ever-growing number of clinical trials available for kidney transplant recipients, including:

• the evaluation of new anti-rejection and anti-infection medication.
• trials assessing the use of different incisions and approaches to surgery, especially minimally invasive procedures performed with laparoscopy or robotics.
• trials to evaluate various combinations of more tolerable treatments.
• to minimize the use of anti-rejection drugs.

While doctors may not be up-to-date on all possible treatment options, your doctor may be able to direct you to national resources on the internet or to other healthcare centers.

Understanding Your Individual Treatment History and Goals

Before asking about available clinical trials, it’s important to understand your diagnosis and specific treatment history. Being informed about your full experience will help your doctor better determine your participation eligibility. Clinical trials have specific eligibility and exclusion criteria:

• eligibility criteria means that to participate, you must meet specific requirements.
• exclusion criteria means you must not have other specific reasons that would prevent you from participating in a trial.

Different trials may have varying levels of potential risk and benefit based on many factors including the type of study, the potential drug or potential therapy that is being tested, and the disease or condition being studied.

This is why it’s important to ask your doctor how trials will differ in meeting your individual needs and goals. It is also important to think about

• how much time you are willing commit
• how far you are willing to travel
• the potential side effects of the trial treatment
• what your goals are for your overall health if you decide to participate

Keeping track of these expectations should help you make an informed decision about participating in a trial.

Starting the Process

If you find a study in which you are interested in participating, you or a member of your transplant team can contact the person listed as the study coordinator or recruitment specialist. During the discussion about your eligibility, be sure to ask questions to confirm your eligibility, find out what the next steps are, and what will be required of you during the trial.

Details such as:

• the frequency of visits.
• personal cost and insurance coverage.
• duration of the trial.
• any required testing (what type and how often).

are important to walk through with the study team.

There are many factors that you must consider to determine if a trial is appropriate for you. The details may sometimes be overwhelming. You should never feel compelled to make a decision, and you should only make a decision until you have learned as much as you can about your disease, your overall health condition, and about various available treatment options. In most instances, you are not permitted to be enrolled in more than one study at a time.

If you find a trial that seems like the right fit for you, let your transplant team know you are interested so that you can talk to them about your options and potential eligibility.

If you are ready to begin searching for trials on your own outside of your transplant center, these are a few resources to explore. Visit ClinicalTrials.gov, which provides recipients and care partners with a national, relatively simple access to information about ongoing clinical trials. Additionally,  WCG Center Watch, American Society of Transplant Surgeons, and American Society for Transplantation have lists of clinical trials that are currently enrolling kidney transplant recipients.