Transplanted Organ RejectionPhase 3FREEDOM-1NCT03995901
A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation
A Phase 3 study testing FCR001 in people with Transplanted Organ Rejection, run by Talaris Therapeutics Inc. at 18 sites in United States.
Trial summary
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplanted Organ Rejection
- What is being tested?
- FCR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 18 sitesUnited States
- Study dates
- 25 Oct 2019to 16 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Recipient age ≥18 years.
- Donor age ≥18 and ≤60 years at time of signing informed consent.
- Recipients of a first or second living donor kidney transplant
- Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and meet all local standard eligibility criteria to donate stem cells for allogeneic transplantation.
- Recipient meets all local standard eligibility criteria for allogeneic stem cell transplant.
- Donors must be deemed eligible as per the requirements of 21CFR1271.
Main Recipient and Donor Exclusion Criteria:
- Recipient and donor who are identical twins.
- Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance [MGRS], monoclonal gammopathy of unknown significance [MGUS]) of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Recipient or donor with known bone marrow aplasia.
Main Recipient-only Exclusion Criteria:
- Multi-organ or stem cell transplant recipient.
- Calculated panel reactive antibodies >80%.
- Recipient is blood type ABO incompatible with donor.
- Presence of donor-specific antibodies (DSA) (positive result) at any time pre-transplant.
- Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive.
- Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma) throughout the course of the study.
- Recipient with a BMI < 18 or > 35 kg/m2.
- Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy.
Main Donor-only Exclusion Criteria:
- Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
The University of Michigan Hospitals & Health System
Ann Arbor, Michigan, 48109
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Mayo Clinic
Jacksonville, Florida, 32224
Scripps Clinic
La Jolla, California, 92037
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
New York-Presbyterian/Weill Cornell
New York, New York, 10065
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
Read the detailed description
The purpose of this randomized (2:1) controlled study is to evaluate the safety, efficacy and overall benefit of FCR001 cell therapy in first or second de novo living donor renal transplantation relative to a standard-of-care control immunosuppression regimen of antibody induction, tacrolimus, mycophenolate, and corticosteroids.
- Conditions
- Transplanted Organ Rejection
- Being tested
- FCR001
- Keywords
- Kidney Transplant, Stem cell therapy, Anti-rejection medications, Living donor kidney transplant, Immune tolerance, Immunosuppression, Immunosuppressive medication, Organ transplant rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCR001Biological
Also called Cell based therapy, Allogeneic stem cell transplant
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
| Study group | Role | What they receive |
|---|---|---|
| FCR001 | Experimental | FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells. Receives: Biological: FCR001 |
| Control | No intervention | Standard induction therapy followed by a maintenance regimen of tacrolimus, mycophenolate, and +/- corticosteroids after kidney transplant. Control donors are not followed beyond randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant
Free from IS is defined as not taking any immunosuppression medications and not having to take immunosuppression medications since their withdrawal.
Biopsy proven acute rejection is defined as Grade ≥1A according to the Banff 2017 Classification of Antibody-Medicated Rejection and T Cell-Mediated Rejection in Renal Allografts (Haas et al 2018).
Measured: 24 months post-transplant
Secondary outcomes (33)
Change in renal function by Modification of Diet in Renal Disease (MDRD4) from post-transplant baseline (Month 1) to Month 24 in FCR001 recipients
Measured: 24 months post-transplant
Proportion of FCR001 recipients free from IS, without BPAR, at Month 36 and 60
Measured: Month 36 and 60 post transplant
Allograft function (eGFR by MDRD4) and change in eGFR from Month 1 to Month 24, 36, and Month 60, by treatment
Measured: Month 1 (post-transplant) to Month 24, 36, and Month 60
Slope and difference in slope of estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD4) over time to Month 24, 36, and 60, by treatment
Measured: Month 24, 36, and 60
Allograft function (eGFR) and change in renal allograft function from Month 1 to Months 24, 36 and 60 by treatment group, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Measured: Month 1 (post transplant) to Month 24, 36, and Month 60
Time to the event for the composite of BPAR, graft loss, death or lost to follow-up and for each component, by treatment group
Measured: Month 1 (post transplant) to Month 6, 12, 24, 36, and 60
Incidence of composite endpoint of BPAR, graft loss or death, by treatment group
Measured: Months 12, 24, 36 and 60
Incidence of composite endpoint of BPAR, graft loss, or death and lost to follow-up, by treatment group
Measured: Months 12, 24, 36 and 60
Incidence of BPAR and treated BPAR by severity, type, and steroid-resistance, by treatment group
Measured: Months 12, 24, 36 and 60
Incidence of acute rejection
Measured: Months 12, 24, 36 and 60
Incidence of de novo donor-specific antibodies
Measured: Months 12, 24, 36 and 60
Incidence or worsening of abnormal histologic findings of cellular or antibody-mediated chronic rejection, chronic glomerulopathy, tubular atrophy and interstitial fibrosis, C4d, calcineurin inhibitor induced damage, disease recurrence, BK nephropathy
Measured: Months 12, 24, 36 and 60
Incidence of renal replacement therapy by treatment group
Measured: Months 12, 24, 36 and 60
Incidence of BPAR or eGFR <50 mL/min by treatment group
Measured: Months 12, 24, 36 and 60
Categorical distribution of eGFR according to chronic kidney disease CKD staging classification by treatment
Measured: Months 12, 24, 36 and 60
Incidence and severity of adverse events (AEs; including infections), serious adverse events (SAEs) and AEs leading to study and/or regimen discontinuation
Measured: Months 12, 24, 36 and 60
Incidence of BK viremia, viruria, infection, and nephropathy by treatment
Measured: Months 12, 24, 36 and 60
Incidence of the adverse events of special interest (proteinuria, neurotoxicity, anemia, diabetes, hypertension, dyslipidemia, opportunistic infections, major adverse cardiovascular events, and malignancies
Measured: Months 12, 24, 36 and 60
Urinary protein and albumin excretion, estimated by urinary protein/creatinine and urinary albumin/creatinine ratios by treatment group
Measured: Months 12, 24, 36 and 60
Subject quality of life according to 36-Item Short Form Health Survey (SF-36) will be analyzed descriptively by treatment group
Measured: Months 12, 24, 36 and 60
Subject quality of life according to End-Stage Renal Disease Symptom Checklist (ESRD-SCL) will be analyzed descriptively by treatment group
Measured: Months 12, 24, 36 and 60
Incidence and duration of hospitalization and readmission, according to type of ward/unit
Measured: Months 12, 24, 36 and 60
iBox predicted allograft survival
Measured: Months 12 and 24 post-transplant
Graft and patient survival and eGFR in FCR001 recipients who are only transiently chimeric
Measured: Month 24, 36, and 60
To describe the incidence and severity of AEs (including infections) and SAEs among FCR001 donors
Measured: Month 24, 36, and 60
Incidence of acute rejection, death, renal graft loss, and lost to follow-up between FCR001 recipients who did not achieve durable chimerism or the ability to wean or remain off immunosuppression vs. the control arm
Measured: Month 24, 36, and 60
The incidence of autologous infusions in FCR001 recipients
Measured: Month 6, 12, 24, 36, and 60
The incidence of engraftment syndrome in FCR001 recipients
Measured: Month 6, 12, 24, 36, and 60
The incidence of blood component transfusions in FCR001 recipients
Measured: Month 6, 12, 24, 36, and 60
The time to neutrophil and platelet recovery in FCR001 recipients
Measured: Month 6, 12, 24, 36, and 60
The incidence of acute and chronic Graft versus Host Disease (GvHD) in FCR001 recipients will be described
Measured: Month 6, 12, 24, 36, and 60
The incidence of donor chimerism and level of chimerism by study visit in FCR001 recipients will be described
Measured: Month 6, 12, 24, 36, and 60
The correlation of donor chimerism with freedom from IS)in FCR001 recipients will be described
Measured: Month 6, 12, 24, 36, and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start25 Oct 2019
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Why it stopped: Talaris decided to discontinue living donor kidney transplant development program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplanted Organ RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talaris Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995901
- Sponsor's protocol ID
- FCR001A2301
- Acronym
- FREEDOM-1
- Status last verified
- Mar 2023
- First submitted
- 13 Jun 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors
- ClinicalTrials.gov ID
- NCT03995901
- Acronym / sponsor ID
- FREEDOM-1 / FCR001A2301
- Conditions
- Transplanted Organ Rejection
- Keywords
- Kidney Transplant, Stem cell therapy, Anti-rejection medications, Living donor kidney transplant, Immune tolerance, Immunosuppression, Immunosuppressive medication, Organ transplant rejection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Talaris decided to discontinue living donor kidney transplant development program
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Talaris Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
Detailed description
The purpose of this randomized (2:1) controlled study is to evaluate the safety, efficacy and overall benefit of FCR001 cell therapy in first or second de novo living donor renal transplantation relative to a standard-of-care control immunosuppression regimen of antibody induction, tacrolimus, mycophenolate, and corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCR001 | Experimental | Biological: FCR001FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells. |
| Control | No intervention | –Standard induction therapy followed by a maintenance regimen of tacrolimus, mycophenolate, and +/- corticosteroids after kidney transplant. Control donors are not followed beyond randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCR001Also: Cell based therapy, Allogeneic stem cell transplantFCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells. | Biological | FCR001 |
Primary outcome
Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant
Time frame: 24 months post-transplant
Free from IS is defined as not taking any immunosuppression medications and not having to take immunosuppression medications since their withdrawal. Biopsy proven acute rejection is defined as Grade ≥1A according to the Banff 2017 Classification of Antibody-Medicated Rejection and T Cell-Mediated Rejection in Renal Allografts (Haas et al 2018).
33 secondary outcomes
Change in renal function by Modification of Diet in Renal Disease (MDRD4) from post-transplant baseline (Month 1) to Month 24 in FCR001 recipients
Time frame: 24 months post-transplant
Proportion of FCR001 recipients free from IS, without BPAR, at Month 36 and 60
Time frame: Month 36 and 60 post transplant
Allograft function (eGFR by MDRD4) and change in eGFR from Month 1 to Month 24, 36, and Month 60, by treatment
Time frame: Month 1 (post-transplant) to Month 24, 36, and Month 60
Slope and difference in slope of estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD4) over time to Month 24, 36, and 60, by treatment
Time frame: Month 24, 36, and 60
Allograft function (eGFR) and change in renal allograft function from Month 1 to Months 24, 36 and 60 by treatment group, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Time frame: Month 1 (post transplant) to Month 24, 36, and Month 60
Time to the event for the composite of BPAR, graft loss, death or lost to follow-up and for each component, by treatment group
Time frame: Month 1 (post transplant) to Month 6, 12, 24, 36, and 60
Incidence of composite endpoint of BPAR, graft loss or death, by treatment group
Time frame: Months 12, 24, 36 and 60
Incidence of composite endpoint of BPAR, graft loss, or death and lost to follow-up, by treatment group
Time frame: Months 12, 24, 36 and 60
Incidence of BPAR and treated BPAR by severity, type, and steroid-resistance, by treatment group
Time frame: Months 12, 24, 36 and 60
Incidence of acute rejection
Time frame: Months 12, 24, 36 and 60
Incidence of de novo donor-specific antibodies
Time frame: Months 12, 24, 36 and 60
Incidence or worsening of abnormal histologic findings of cellular or antibody-mediated chronic rejection, chronic glomerulopathy, tubular atrophy and interstitial fibrosis, C4d, calcineurin inhibitor induced damage, disease recurrence, BK nephropathy
Time frame: Months 12, 24, 36 and 60
Incidence of renal replacement therapy by treatment group
Time frame: Months 12, 24, 36 and 60
Incidence of BPAR or eGFR <50 mL/min by treatment group
Time frame: Months 12, 24, 36 and 60
Categorical distribution of eGFR according to chronic kidney disease CKD staging classification by treatment
Time frame: Months 12, 24, 36 and 60
Incidence and severity of adverse events (AEs; including infections), serious adverse events (SAEs) and AEs leading to study and/or regimen discontinuation
Time frame: Months 12, 24, 36 and 60
Incidence of BK viremia, viruria, infection, and nephropathy by treatment
Time frame: Months 12, 24, 36 and 60
Incidence of the adverse events of special interest (proteinuria, neurotoxicity, anemia, diabetes, hypertension, dyslipidemia, opportunistic infections, major adverse cardiovascular events, and malignancies
Time frame: Months 12, 24, 36 and 60
Urinary protein and albumin excretion, estimated by urinary protein/creatinine and urinary albumin/creatinine ratios by treatment group
Time frame: Months 12, 24, 36 and 60
Subject quality of life according to 36-Item Short Form Health Survey (SF-36) will be analyzed descriptively by treatment group
Time frame: Months 12, 24, 36 and 60
Subject quality of life according to End-Stage Renal Disease Symptom Checklist (ESRD-SCL) will be analyzed descriptively by treatment group
Time frame: Months 12, 24, 36 and 60
Incidence and duration of hospitalization and readmission, according to type of ward/unit
Time frame: Months 12, 24, 36 and 60
iBox predicted allograft survival
Time frame: Months 12 and 24 post-transplant
Graft and patient survival and eGFR in FCR001 recipients who are only transiently chimeric
Time frame: Month 24, 36, and 60
To describe the incidence and severity of AEs (including infections) and SAEs among FCR001 donors
Time frame: Month 24, 36, and 60
Incidence of acute rejection, death, renal graft loss, and lost to follow-up between FCR001 recipients who did not achieve durable chimerism or the ability to wean or remain off immunosuppression vs. the control arm
Time frame: Month 24, 36, and 60
The incidence of autologous infusions in FCR001 recipients
Time frame: Month 6, 12, 24, 36, and 60
The incidence of engraftment syndrome in FCR001 recipients
Time frame: Month 6, 12, 24, 36, and 60
The incidence of blood component transfusions in FCR001 recipients
Time frame: Month 6, 12, 24, 36, and 60
The time to neutrophil and platelet recovery in FCR001 recipients
Time frame: Month 6, 12, 24, 36, and 60
The incidence of acute and chronic Graft versus Host Disease (GvHD) in FCR001 recipients will be described
Time frame: Month 6, 12, 24, 36, and 60
The incidence of donor chimerism and level of chimerism by study visit in FCR001 recipients will be described
Time frame: Month 6, 12, 24, 36, and 60
The correlation of donor chimerism with freedom from IS)in FCR001 recipients will be described
Time frame: Month 6, 12, 24, 36, and 60
Results and safety
The study was stopped early (reason given: Talaris decided to discontinue living donor kidney transplant development program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FCR001 in people with Transplanted Organ Rejection, run by Talaris Therapeutics Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Talaris decided to discontinue living donor kidney transplant development program). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant (time frame: 24 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.