Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Imminent Neurological Deaths
• Age: Between 0 years - 99 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. You are a recipient of a de novo kidney from a living or deceased donor and has biopsy-proven, pFSGS as a cause of end stage renal disease (ESRD) in their native kidneys (pre-existing biopsy reports from the referring physicians are allowed) or a previously transplanted kidney that has failed.
  2. Female subject must either: Be of none-child bearing potential-post menopausal prior to screening or documented surgically sterile; or if of childbearing potential, agree not to try to become pregnant during the study and for 90 days post last dose
  3. Female subject must agree not to breastfeed starting at screening, throughout the study and for 90 days post-last dose.
  4. Female subject must not donate ova starting at screening, throughout the study and for 90 days post-last dose.
  5. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective form of contraception consisting of two forms of birth control* (at least one of which must be a barrier method) starting at screening, throughout the study and for 90 days post-last dose.
  6. Male subject must not donate sperm starting at screening, throughout the study and for 90 days post-last dose.
  7. Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
  8. Subject agrees not to participate in another interventional study while on treatment.

  
  

You may not be eligible for this study if the following are true:

• 1. You have Induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen.
  2. You have a diagnosis of secondary FSGS (familial, virus associated, medication, etc., protocol Appendix 12.5) or a defined genetic cause of FSGS.
  3. You will receive a kidney as part of a multi-organ transplant.
  4. You will receive a dual kidney transplant from a deceased donor.
  5. You will receive a kidney with an anticipated cold ischemia time of > 30 hours.
  6. You 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.)
  7. You will receive a blood group system (A, AB, B, O, ABO) incompatible donor kidney.
  8. You are seropositive for human immunodeficiency virus (HIV).
  9. You have a current calculated panel reactive antibody (cPRA) level > 50%.
  10. You have a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been successfully treated, or a renal cell carcinoma that has been treated successfully more than 2 years prior to transplantation.
  11. You have a significant liver disease, defined as having during the past 21 days consistently elevated aspartate aminotransferase (SGOT) (AST) and/or alanine aminotransferase (SGPT) (ALT) levels greater than 1.5 times the upper value of the normal range of the investigational site.
  12. You have a positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial therapy/or would require TB prophylaxis after transplant.
  13. You have an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
  14. You are concurrently participating in another drug study or has received an investigational drug up to 30 days or 5 half-lives (depending on medication) prior to transplant.
  15. You are receiving or has received up to 8 weeks prior to transplant an immunologic biologic compound (i.e., tumor necrosis factor inhibitors, [e.g., etanercept, adalimumab], intravenous immunoglobulin).
  16. You have previously received bleselumab or participated in a clinical study with bleselumab.
  17. You have a known hypersensitivity to tacrolimus, mycophenolate, basiliximab, corticosteroids, or any of their components.
  18. You have any form of substance abuse, psychiatric disorder, or a condition that in the opinion of the Investigator could invalidate communication with the Investigator.
  19. You have a clinically significant abnormal electrocardiogram (ECG) at screening.