Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Inf… (NCT00497926) | Clinical Trial Compass
TerminatedPhase 2
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Stopped: living donor kidney program terminated due to slow pace of phase 3 study enrollment
United States37 participantsStarted 2008-03
Plain-language summary
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
* Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation
* Patient is receiving a renal transplant only
* The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis.
* Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion
* Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF
* No evidence of donor-specific antibody presently or historically
* Panel Reactive Antibody (PRA) less than or equal to 20
Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four-hour drive, for the first month of the protocol so that they can be monitored closely in the early post-transplant period.
Exclusion Criteria:
* Clinically active bacterial, fungal, viral or parasitic …