What could the FREEDOM trials mean for your patients?
Overview of the FREEDOM-1 clinical trial
Help your patients find freedom with the power of two
The FREEDOM-1 clinical trial is a phase 3, randomized, controlled trial that will evaluate the safety and efficacy of an investigational cell therapy called FCR001 in living donor kidney transplant recipients and safety in kidney donors.
To learn more about the FREEDOM-1 clinical trial please visit ClinicalTrials.gov: NCT03995901
Who can take part in FREEDOM-1?
We are looking for 120 recipient and donor pairs (2:1 [treatment:control]).
Recipients must:
Be at least 18 years old
Be willing to take part in the trial for about five years
Have a living kidney donor who is also willing and eligible to take part*
*Study participants are responsible for finding their own kidney donor. However, resources are available to help guide this process. Please refer your patients to the resources page on the patient website or directly to National Kidney Foundation's Living Donation page to learn more about finding a donor.
Could your patient participate?
FREEDOM-1 recipient timeline
Treatment group (FCR001)
About 5 years with at least 34 total study visits
Mobilization/apheresis
All participants will complete mobilization (with filgrastim) and apheresis
- Donors—to collect cells for FCR001
- Recipients—to collect autologous rescue product
Conditioning
- Recipients will receive conditioning medicines (fludarabine, cyclophosphamide, and mesna) and a single low dose of radiation
- Hemodialysis will be required after each round of conditioning medicines
Kidney transplant
- Recipients will undergo the kidney transplant
Stem cell transplant
- One day after the kidney transplant, recipients will receive the investigational stem cell transplant
Monitoring period
- Recipients will receive conventional immunosuppressive medicines twice daily (mycophenolate [MMF] and tacrolimus)
- MMF may stop after six months and tacrolimus after one year if study criteria are met
- Recipients will have regular study visits after their transplant so the study team can continue to monitor their health
- Donors will have at least ten visits over 12 months
Control (standard of care)
About 5 years with at least 21 total study visits
Kidney transplant
- Recipients will undergo the kidney transplant with standard induction and immunosuppressant maintenance
Monitoring period
- Recipients will receive immunosuppressive medicines
- Recipients will have regular study visits after their transplant so the study team can continue to monitor their health
- Donors will end participation after screening
Participants may experience side effects and/or health complications from the medicines,
investigational cell therapy, and/or assessments and procedures.
Overview of the FREEDOM-2 clinical trial
The future starts with two
The FREEDOM-2 clinical trial is a phase 2, single-arm, multi-center, open-label trial that will evaluate the safety and efficacy of an investigational cell therapy called FCR001 in living donor kidney transplant recipients 3 to 12 months after their transplant and safety in kidney donors.
To learn more about the FREEDOM-2 clinical trial please visit ClinicalTrials.gov: NCT01649388
Who can take part in FREEDOM-2?
We are looking for 15 recipient and donor pairs.
Recipients must:
Be at least 18 years old
Have received a kidney transplant from a living kidney donor (who must also willing and eligible to take part) 3 to 12 months before the screening visit
Have not experienced any episodes of rejection
Have stable kidney function
Could your patient participate?
FREEDOM-2 recipient timeline
All recipients receive FCR001
About 5 years with at least 33 total study visits
Mobilization/apheresis
All participants will complete mobilization (with filgrastim) and apheresis
- Donors—to collect cells for FCR001
- Recipients—to collect autologous rescue product
Conditioning
- Recipients will receive conditioning medicines (fludarabine, cyclophosphamide, and mesna) and a single low dose of radiation
Stem cell transplant
- Recipients will receive the stem cell transplant with FCR001
Monitoring period
- Recipients will receive conventional immunosuppressive medicines twice daily (mycophenolate [MMF] and tacrolimus)
- MMF may stop after six months and tacrolimus after one year if study criteria are met
- Recipients will have regular study visits after their transplant so the study team can continue to monitor their health
- Donors will have at least eight study visits over about 15 months
Participants may experience side effects and/or health complications from the medicines,
investigational cell therapy, and/or assessments and procedures.
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