In Partnership with CSL Behring

Clinical trials for transplant recipients evaluate different types of potential treatments in individuals who are waiting for or have already received a transplant. These studies may examine new anti-rejection and anti-infection drugs, new approaches to surgery, or new combinations of treatments.

The goal of clinical trials is to gain knowledge and understanding whether potential study treatments can safely and effectively meet certain study criteria, such as prolonging life expectancy, prolonging survival of the transplanted organ(s), improving a person’s quality of life, and improving current medications.

What is the Process to be Accepted for a Kidney Transplant Clinical Trial?

Prior to being accepted to a clinical trial, you will be screened to make sure that you qualify for the trial based on inclusion 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.

If accepted into the trial, the first visit consists of required testing, such as cognitive and/or physical tests. If the study is a randomized controlled trial (RCT), you will be randomly assigned to a treatment or control group. The randomization process determines:

  • who receives the medication or procedure (treatment group)
  • who receives a placebo or standard procedure (control group).

Randomization is usually done by a computer program. Randomization may be blind, which means that the doctor (PI) and/or the study coordinator may or may not know what study therapy the participants receive.

Deciding Whether or Not to Participate in a Clinical Trial

Before you agree to participate in a clinical trial, an investigator and/or a study coordinator will explain to you in detail:

  • the goals and purpose of the designated clinical trial
  • the plan and methods for any required visits and tests
  • the possible side effects of the tested agent that you may experience
  • how participation in the study might affect your daily life
  • how your transplant might be affected by or without the treatment
  • and what is expected to happen to you and your transplant during the clinical trial itself and predictably afterwards.

During this initial discussion about the trial, you will have the opportunity to ask any questions that you might have about the clinical trial, including the potential results and any concerns about complications. The research team will give you an “informed consent form” that explains the details of the clinical trial, including known risks and side effects and their potential severity. You will be informed about the voluntary entry and exit from the study, the process of being in the study, and reasons why you may need to be removed from the study. You may also review and share this form with your doctor, care partner, or family, when deciding if enrolling in a clinical study is right for you.

If you decide to take part in the clinical trial, you will sign the informed consent form in the presence of someone from the study team. This will likely be either the principal investigator (PI) of the study or your primary transplant physician, depending on how the study is set up. After you sign the informed consent form, you can change your mind and withdraw from the clinical trial at any time, and for any reason or no reason at all, either before or during the trial.  Deciding not to be in a clinical study, or leaving a clinical study at any time will not jeopardize your medical treatment you would otherwise receive.

What to Expect During a Clinical Trial

Throughout the trial, trial participants must report any issues or concerns to the research team. There will be regularly scheduled visits for evaluations, testing and discussions. Some follow-up visits may also be conducted by video or telephone. During these visits, the research team collects information about the effects of the treatment and reviews each participant’s health and safety. When the trial concludes, you will no longer have scheduled visits and testing specifically for the study, but you may continue to be seen regularly by the doctor or PI of the trial. Furthermore, you will no longer receive the treatment being studied after the trial, unless explicitly allowed.

In Partnership with CSL Behring

Possible Benefits of Being Part of a Clinical Trial

As a research participant, you help researchers explore potential new treatments. Through participating in a clinical trial, you may also learn more about your condition, which can help in your disease management. The insights that come from research studies help those in the medical field learn new ways to help others with your condition.

Possible Risks of Being Part of a Clinical Trial

Research participation does not come without risks. The study treatment or study medication being tested may not make you feel better, or could make you feel worse, for many reasons, including:

  • interacting with your other medications
  • starting at an unideal time in the course of your disease progression
  • not working in humans like it did in earlier experiments
  • working better in one sex or certain racial/ethnic background
  • risks inherent to the study drug or how it is administered

New treatments are not always better than standard treatments and could, for instance, potentially be less safe or less effective, or could potentially interfere with the treatments you are currently receiving. You will likely have more medical visits, and you may spend additional funds on matters such as travel. The cost of medications and tests that are not part of your standard of care may be covered by the study, but it’s important to review this with the study staff to ensure you’re fully informed before you decide to participate. There is also the risk that the treatment may have known or unknown side effects, which can result in various types of complications. The study will be stopped by an independent group of scientists (called an Institutional Review Board) if the rights and welfare of the study subjects are not properly protected.

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.