The basics of research
A clinical trial is a type of medical research that works to answer specific questions, such as:
- Is the investigational therapy safe?
- Does the investigational therapy work?
Like many clinical trials, the FREEDOM trials will focus on learning more about a potential treatment to see if it could help people with a specific disease or condition—in this case, kidney transplant recipients and their living donors.
Could you take part?
Take a short survey to find out if you could qualify for one of the FREEDOM clinical trials.
Research safety
Participant safety is the most important part of any trial.
Before any clinical trial can begin, institutional review boards (IRBs) review the trial to ensure that the rights, welfare, and safety of all trial participants will be protected. The FREEDOM trials have been approved by IRBs at all of the trial sites.
During the trial, participants’ health is closely monitored by the study team. If their health gets worse, the study team will decide the safest way to continue, which could include changing to a different medication or leaving the trial completely.
What does the phase of a trial mean?
Before a treatment can be approved to be used by the public, it must go through several stages of research called phases.
Phase 1
A small group of healthy people are given the investigational therapy to learn about the dose and potential side effects.
Phase 2
A larger group of people with the condition being studied are given the investigational therapy to learn if it could be safe and effective.
The FREEDOM-2 clinical trial is a phase 2 study.
Phase 3
An even larger group of people with the condition being studied are given the investigational therapy to learn if it could be safe and effective, and to compare it against existing treatments (the standard of care) or a placebo (a fake drug).
The FREEDOM-1 clinical trial is a phase 3 study. There is no placebo used in either FREEDOM-1 or FREEDOM-2.
Treatment reviewed by the FDA.
Phase 4
These trials take place once an investigational therapy has been approved by the FDA for use. They help us learn how the treatment affects people in the long term.
Definitions
Some terms you may hear during the FREEDOM trials and what they mean.
The investigational cell therapy being researched in the FREEDOM clinical trials is called FCR001. FCR001 is administered intravenously (given into a vein) as a one-time infusion. Investigational means it is still being developed and has not been approved by the FDA for use by the general public.
In the FREEDOM-1 trial, recipients in the control group receive the standard of care currently used in people living with a kidney transplant (immunosuppressive medicines). Donors in the control group end their study participation after the screening visit(s).
Controls are used in clinical trials to see how the investigational treatment works when compared to the standard of care.
There is no control group in the FREEDOM-2 trial.
Participants in the treatment group of a clinical trial will receive the investigational therapy.
A currently approved treatment plan for a specific condition. For kidney transplant recipients, this is usually immunosuppressive medicines.
Health checks that take place during clinic visits. In the FREEDOM clinical trials, these can include things like blood draws, physical exams, and kidney biopsies. Your study team will let you know what to expect at each visit.
Before you decide to take part in a trial, you will receive an informed consent form to read and sign to ensure you understand the trial in full. The form describes what you should expect from the trial, including timelines, procedures and assessments, and potential risks and benefits of taking part. The study team will discuss this with you in more detail and answer any questions you may have.
The written plan that describes the trial in detail, including the need for the trial, who can take part, and what happens at every clinic visit.
The FREEDOM trials
Explore the details of the FREEDOM clinical trials.
