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A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation (FREEDOM-1)

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ClinicalTrials.gov Identifier: NCT03995901
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Talaris Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE October 25, 2019
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
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 Grade ≥1A according to the Banff 2017 Classification of Antibody-Medicated Rejection and T Cell-Mediated Rejection in Renal Allografts (Haas et al 2018).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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 ]
    Renal function is evaluated by estimated glomerular filtration rate (eGFR) calculated using the MDRD4 formula (Coresh et al. 2003). Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where C is the serum concentration of creatinine [mg/dL], A is patient age at sample collection date [years], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.
  • Proportion of FCR001 recipients free from IS, without BPAR, at Month 36 and 60 [ Time Frame: Month 36 and 60 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).
  • 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 ]
    Renal function is evaluated by estimated glomerular filtration rate (eGFR) calculated with the MDRD4 formula (Coresh et al. 2003). This formula is based on the four (4) variables of age, gender, ethnicity and serum creatinine.
  • 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 ]
    Estimated glomerular filtration rate (eGFR) is calculated with the MDRD4 formula (Coresh et al. 2003).
  • Allograft function (eGFR) and change in renal allograft function from Month 1 to Months 24, 36 and 60 by treatment group, using the CKD-EPI formula [ Time Frame: Month 1 (post transplant) to Month 24, 36, and Month 60 ]
    Estimated glomerular filtration rate (eGFR) is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (Levey et al. 2009).
  • 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 ]
    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). Graft loss is defined as 56 consecutive days of hemodialysis or re-transplantation. Loss to follow-up is a subject whose status is unclear because he/she fails to appear for study visits without stating an intention to withdraw and did not respond to repeated attempts of contact, who did not experience graft loss or death from Day 1 and whose last day of contact was prior to study Month 60.
  • Incidence of composite endpoint of BPAR, graft loss or death, by treatment group [ Time Frame: Months 12, 24, 36 and 60 ]
    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). Graft loss is defined by 56 consecutive days of hemodialysis or re-transplantation.
  • 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 ]
    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). Graft loss is defined as 56 consecutive days of hemodialysis or re-transplantation. Loss to follow-up is a subject whose status is unclear because he/she fails to appear for study visits without stating an intention to withdraw and did not respond to repeated attempts of contact, who did not experience graft loss or death from Day 1 and whose last day of contact was prior to study Month 60.
  • Incidence of BPAR and treated BPAR by severity and type (Banff 2017) and steroid-resistance, by treatment group [ Time Frame: Months 12, 24, 36 and 60 ]
    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). Treated BPAR are those BPARs treated with antirejection medications. BPAR and treated BPAR will be characterized by severity, type and steroid resistance.
  • Incidence of acute rejection [ Time Frame: Months 12, 24, 36 and 60 ]
    Acute rejection includes both clinically suspected and BPAR Grade ≥1A according to the Banff 2017 Classification of Antibody-Medicated Rejection and T Cell-Mediated Rejection in Renal Allografts (Haas et al 2018).
  • Incidence of de novo donor-specific antibodies [ Time Frame: Months 12, 24, 36 and 60 ]
    Newly formed anti-human leukocyte donor-specific antibodies
  • 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 [ Time Frame: Months 12, 24, 36 and 60 ]
    Kidney biopsies will be assessed for new or worsening abnormal histologic findings of cellular or antibody-mediated chronic rejection, chronic glomerulopathy, renal tubular atrophy and interstitial fibrosis, C4d (degradation product of activated complement factor C4 and is a sensitive marker for antibody-dependent humoral rejection) in peritubular capillaries, calcineurin inhibitor induced damage, recurrence of the primary condition leading to renal transplant, and BK viral nephropathy.
  • Incidence of renal replacement therapy by treatment group [ Time Frame: Months 12, 24, 36 and 60 ]
    Renal replacement therapy is defined by the need for hemodialysis following kidney transplant which is not due to delayed graft function.
  • Incidence of BPAR or eGFR <50 mL/min by treatment group [ Time Frame: Months 12, 24, 36 and 60 ]
    BPAR Grade ≥1A according to the Banff 2017 Classification of Antibody-Medicated Rejection and T Cell-Mediated Rejection in Renal Allografts (Haas et al 2018). Estimated glomerular filtration rate (eGFR) is calculated using the MDRD4 formula (Coresh et al. 2003).
  • Categorical distribution of eGFR according to CKD staging classification by treatment [ Time Frame: Months 12, 24, 36 and 60 ]
    Estimated glomerular filtration rate (eGFR), calculated by the MDRD4 formula (Coresh et al. 2003), is used to determine the stage of chronic kidney disease (CKD). The 5 stages of CKD based on GFR are: Stage 1 is GFR ≥ 90 mL/min/1.73 m^2; Stage 2 is GFR from 60 to 89 mL/min/1.73 m^2; Stage 3 is GFR from 30 to 59 mL/min/1.73 m^2; Stage 4 is GFR from 15 to 29 mL/min/1.73 m^2 and Stage 5 is GFR <15 mL/min/1.73 m^2.
  • Incidence and severity of adverse events (AEs; including infections), serious adverse events (SAEs) [ Time Frame: Months 12, 24, 36 and 60 ]
    An Adverse Event (AE) is any untoward medical occurrence (ie, any unfavorable and unintended sign, symptom or disease). A Serious Adverse Event is defined as any AE (appearance of or worsening of any pre-existing undesirable sign, symptom or medical conditions) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant
  • Incidence of BK viremia, viruria, infection, and nephropathy by treatment [ Time Frame: Months 12, 24, 36 and 60 ]
    BK virus infection is defined by virus detected by PCR-based assay in blood (viremia) or urine (viruria). BK infection of the kidney is defined as histologic evidence of BK viral infection on kidney biopsy and positive BK virus detected in blood or urine.
  • Incidence of the adverse events of proteinuria, neurotoxicity, anemia, diabetes, hypertension, and dyslipidemia and their composite, by treatment [ Time Frame: Months 12, 24, 36 and 60 ]
    Adverse event reporting of proteinuria, neurotoxicity, anemia, diabetes, hypertension, and dyslipidemia.
  • 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 ]
    Proteinuria, a marker of renal dysfunction, is assessed by a urinary protein/creatinine ratio using urine sample protein and creatinine concentration measures. The ratio is a surrogate for a 24-hour urinary protein measurement. Similarly, a urinary albumin/creatinine ratio is a sensitive assessment of low levels of urine proteinuria.
  • Incidence of major cardiovascular events and malignancies by treatment group [ Time Frame: Months 12, 24, 36 and 60 ]
    Adverse events of major cardiovascular events and malignancies.
  • 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 ]
    The 36-Item Short Form Health Survey is a patient-reported outcome measure which assesses overall physical function, general health and social/psychological factors. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
  • 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 ]
    The End-Stage Renal Disease Symptom Checklist (ESRD-SCL) is also an outcome measure developed specifically for and validated in the end stage renal disease population. The ESRD-SCL covers six dimensions with a total of 43 items: limited physical capacity (10 items), limited cognitive capacity (8 items), cardiac and renal dysfunction (7 items), side effects of corticosteroids (5 items), increased hair and gum growth (5 items) as well as transplantation-associated psychological distress (8 items). All questions are scored on a five-point Likert scale. The higher the score the more unfavorable symptoms were reported.
  • Incidence and duration of hospitalization and readmission, according to type of ward/unit [ Time Frame: Months 12, 24, 36 and 60 ]
    Hospital admissions and readmission by ward/unit and duration will be collected through serious adverse event reporting.
  • Graft and patient survival and eGFR in FCR001 recipients who are only transiently chimeric [ Time Frame: Month 24, 36, and 60 ]
    Graft loss and death are used to determine graft survival and patient survival respectively. Both will be evaluated in FCR001 recipients who achieve a donor chimerism of >50% donor T-cells measured in recipient blood but then falls below 50% T-cells. Graft loss is defined as 56 consecutive days of hemodialysis or re-transplantation.
  • To describe the incidence and severity of AEs (including infections) and SAEs among FCR001 donors [ Time Frame: Month 24, 36, and 60 ]
    An Adverse Event is any untoward medical occurrence (ie, any unfavorable and unintended sign, symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A Serious Adverse Event is defined as any AE (appearance of or worsening of any pre-existing undesirable sign, symptom or medical conditions) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant. Adverse events and Serious Adverse Events for FCR001 donors will be summarized.
  • 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 ]
    In this composite endpoint, acute rejection is defined as a BPAR Grade ≥1A according to the Banff 2017 Classification of Antibody-Medicated Rejection and T Cell-Mediated Rejection in Renal Allografts (Haas et al 2018). Renal graft loss is defined as 56 consecutive days of hemodialysis or re-transplantation. Loss to follow-up is a subject whose status is unclear because he/she fails to appear for study visits without stating an intention to withdraw and did not respond to repeated attempts of contact, who did not experience graft loss or death from Day 1 and whose last day of contact was prior to study Month 60. Durable chimerism is defined as maintaining at least 50% donor T-cells measured in recipient blood. For FCR recipients, inability to wean immunosuppression is defined as not meeting the criteria (BPAR >1A, chimerism <50% T-cells of donor, no graft versus host disease and having stable renal function) to discontinue their antirejection medications. Inability to remain
  • The incidence of autologous infusions in FCR001 recipients [ Time Frame: Month 6, 12, 24, 36, and 60 ]
    Autologous hematopoietic stem cell transplantation for FCR001 recipients using their reserved frozen cells obtained prior to renal transplantation may be performed, only when medically warranted for safety reasons.
  • The incidence of engraftment syndrome in FCR001 recipients. [ Time Frame: Month 6, 12, 24, 36, and 60 ]
    Engraftment syndrome is a clinical condition which can occur in recipients of hematopoietic stem cell transplantation that is characterized by some or all of the following: fever, skin rash, pulmonary edema, weight gain, liver, renal dysfunction and encephalopathy. This syndrome typically presents at the time of neutrophil recovery after hematopoietic stem cell transplantation.
  • The incidence of blood component transfusions in FCR001 recipients [ Time Frame: Month 6, 12, 24, 36, and 60 ]
    Blood component transfusions include platelets, packed red blood cells, plasma and blood-clotting factor.
  • The time to neutrophil and platelet recovery in FCR001 recipients. [ Time Frame: Month 6, 12, 24, 36, and 60 ]
    Time to neutrophil and platelet recovery is defined as the time it takes absolute neutrophil count to recover to > 500 cells/µL and platelet count to recover to >50K from their depression following conditioning therapy in preparation of FCR001 recipients to receive FCR001 cell therapy.
  • 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 ]
    Graft versus host disease (GvHD) occurs when the donor's T cells (the graft) view the patient's healthy cells (the host) as foreign, and attack and damage them. Acute and chronic GvHD will be reported as adverse events.
  • 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 ]
    Donor chimerism is defined by > 50% donor T-cells measured in recipient blood.
  • The correlation of donor chimerism with freedom from immunosuppression (IS) in FCR001 recipients will be described. [ Time Frame: Month 6, 12, 24, 36, and 60 ]
    Freedom from immunosuppression is defined as the ability to discontinue anti-rejection medications and not having to restart any antirejection medication. Donor chimerism is defined by > 50% donor T-cells measured in recipient blood.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation
Official Title  ICMJE 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
Brief Summary A randomized controlled study to assess the safety and 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 assess the safety, efficacy and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation relative to a standard-of-care control immunosuppression regimen of antibody induction, tacrolimus, mycophenolate, and corticosteroids.

FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells. This therapy induces or restores patients' immune tolerance by establishing stable donor chimerism in the transplant recipient without the need for life-long immunosuppression.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transplanted Organ Rejection
Intervention  ICMJE Biological: FCR001
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.
Other Names:
  • Cell based therapy
  • Allogeneic stem cell transplant
Study Arms  ICMJE
  • Experimental: FCR001
    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.
    Intervention: Biological: FCR001
  • No Intervention: Control

    Standard induction therapy followed by a maintenance regimen of tacrolimus, mycophenolate, and corticosteroids after kidney transplant.

    Control donors are not followed beyond randomization.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2026
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent must be obtained, from recipients and donors, before any assessment is performed on the respective subject.
  2. Recipient age ≥18 years.
  3. Donor age ≥18 and ≤60 years
  4. Recipients of a first kidney transplant from a living unrelated or non- human leukocyte antigen (HLA) identical living related donor.
  5. Donor willing to undergo mobilization, apheresis and 12-month safety follow-up.

Recipient and Donor Exclusion Criteria:

  1. Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
  2. Recipient or donor with history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  3. Recipient and donor who are identical twins.
  4. Recipient or donor who is a pregnant or nursing (lactating) woman.
  5. Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome) 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.
  6. Recipient or donor with known bone marrow aplasia.

Recipient-only Exclusion Criteria:

  1. Multi-organ or cell transplant recipient.
  2. Panel reactive antibodies (calculated panel reactive antibody>20% by Flow/Luminex).
  3. Recipient is blood type ABO incompatible or has positive crossmatch (Flow/Luminex) vs. donor.
  4. Presence of donor-specific antibodies (DSA) at any time pre-transplant.
  5. Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive.
  6. Recipient with systemic infection, current or within the 2 weeks prior to conditioning; or history of recurrent infection (eg, polycystic liver/kidney disease, unless native kidneys removed at time of transplant).
  7. 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.
  8. Recipient who had a live attenuated vaccine administered within 2 months of planned transplant surgery.
  9. Recipient with a BMI < 18 or > 35 kg/m2.
  10. Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy.
  11. Recipient with contraindication to total body irradiation (TBI) according to local radiologist, eg, previous radiation therapy at a dose which would preclude TBI, inadequate pulmonary function.
  12. Recipient with autologous or allogeneic hematopoietic progenitor cell transplant prior to signing informed consent.
  13. All recipient women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to using highly effective methods of contraception during dosing of study treatment.
  14. Sexually active male control recipient must use a condom during intercourse throughout the study and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of drugs via seminal fluid. FRC001 recipient this requirement may be lifted at 6 weeks after MMF and tacrolimus have been discontinued.

Donor-only Exclusion Criteria:

  1. Biologically unrelated female donor transplant to male recipient.
  2. Donor tested positive for Zika virus (ZIKV) infection. Zika infection is excluded by negative nucleic acid testing result on either serum or urine PLUS a negative Zika IgM. Only donors with the following risk factors must be tested:

    1. Medical diagnosis of ZIKV in the past 6 months.
    2. Residence in, or travel to, an area with an increased risk for ZIKV transmission within the past 6 months.
    3. Sex within the past 6 months with a person who has either of the risk factors listed in items (a) or (b), above.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ken Abrams, MD (617) 655-7545 ken.abrams@talaristx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995901
Other Study ID Numbers  ICMJE FCR001A2301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Talaris Therapeutics Inc.
Study Sponsor  ICMJE Talaris Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nancy Krieger, MD Talaris Therapeutics Inc.
PRS Account Talaris Therapeutics Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP