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 (the FREEDOM-1 study)
Categories (click each to see list of all clinical trials associated with that category): Bone Marrow Transplant (BMT)/Graft Versus Host Disease (GVHD)
Current Status: Open to accrual
Phase: III
Principal Investigator: Miles, Clifford
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03995901?cond=NCT03995901&draw=2&rank=1#eligibility
Summary
Primary: Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant
Secondary: 1. Change in renal function by Modification of Diet in Renal Disease (MDRD4) from post-transplant baseline (Month 1) to Month 24 in FCR001 recipients 2. Proportion of FCR001 recipients free from IS, without BPAR, at Month 36 and 60 3. Allograft function (eGFR by MDRD4) and change in eGFR from Month 1 to Month 24, 36, and Month 60, by treatment 4. 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 5. 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 6. Time to the event for the composite of BPAR, graft loss, death or lost to follow-up and for each component, by treatment group 7. Incidence of composite endpoint of BPAR, graft loss or death, by treatment group 8. Incidence of composite endpoint of BPAR, graft loss, or death and lost to follow-up, by treatment group 9. Incidence of BPAR and treated BPAR by severity and type (Banff 2017) and steroid-resistance, by treatment group 10. Incidence of acute rejection 11. Incidence of de novo donor-specific antibodies 12. 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 13. Incidence of renal replacement therapy by treatment group 14. Incidence of BPAR or eGFR <50 mL/min by treatment group 15. Categorical distribution of eGFR according to CKD staging classification by treatment 16. Incidence and severity of adverse events (AEs; including infections), serious adverse events (SAEs) 17. Incidence of BK viremia, viruria, infection, and nephropathy by treatment 18. Incidence of the adverse events of proteinuria, neurotoxicity, anemia, diabetes, hypertension, and dyslipidemia and their composite, by treatment 19. Urinary protein and albumin excretion, estimated by urinary protein/creatinine and urinary albumin/creatinine ratios by treatment group 20. Incidence of major cardiovascular events and malignancies by treatment group 21.Subject quality of life according to 36-Item Short Form Health Survey (SF-36) will be analyzed descriptively by treatment group 22. Subject quality of life according to End-Stage Renal Disease Symptom Checklist (ESRD-SCL) will be analyzed descriptively by treatment group 23. Incidence and duration of hospitalization and readmission, according to type of ward/unit 24. Graft and patient survival and eGFR in FCR001 recipients who are only transiently chimeric 25. To describe the incidence and severity of AEs (including infections) and SAEs among FCR001 donors 26. 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 27. The incidence of autologous infusions in FCR001 recipients 28. The incidence of engraftment syndrome in FCR001 recipients 29. The incidence of blood component transfusions in FCR001 recipients 30. The time to neutrophil and platelet recovery in FCR001 recipients 31. The incidence of acute and chronic Graft versus Host Disease (GvHD) in FCR001 recipients will be described 32. The incidence of donor chimerism and level of chimerism by study visit in FCR001 recipients will be described 33. The correlation of donor chimerism with freedom from immunosuppression (IS) in FCR001 recipients will be described.