Principal Investigator: Simin Goral, MD,
Type Of Study: Randomized Open-Label Trial
Brief Description Of Study: The Bleselumab study is a randomized study to assess the use of study drug Bleselumab or standard of care in preventing recurrence of FSGS in first time kidney transplant recipients.
Detailed Study Description: This is A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in denovo Kidney Transplant Recipients. Approximately 45 investigative centers in North America will plan to enroll 60 male and female subjects 18 years of age or older who are de novo, living or deceased donor kidney recipients and have biopsy-proven primary focal segmental glomerulosclerosis (pFSGS).
General Inclusion Criteria: Adult de novo kidney transplant recipients from a living or deceased donor and has biopsy-proven, pFSGS as a cause of ESRD in their native kidneys (initial diagnosing biopsy report is required). A subject who has biopsy-proven pFSGS as a cause of ESRD, and their most current graft failure(s) is due to biopsy-proven, recurrent FSGS, is eligible..
General Exclusion Criteria:
- Inability to provide informed consent;
- Diagnosis of secondary FSGS
- Subject has previously received any organ transplant including a kidney and the most currentgraft failure(s) is not due to the recurrence of FSGS.
- Subject will receive a kidney as part of a multi-organ transplant.
- Subject will receive a dual kidney transplant from a deceased donor.
- Subject will receive a kidney with an anticipated cold ischemia time of > 30 hours.
- Subject will receive a kidney that meets BOTH Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. (A kidney that meets either ECD OR DCD criteria may be
eligible for inclusion.)
Dr. Simin Goral
Jennifer Trofe-Clark, PharmD
Robin Neubauer, RN