Clinical Trials

Inclusion Criteria:

• Able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent.
• Male or female ≥ 18 years of age.
• Recipient of their first kidney transplant from a living or deceased donor.
• Willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
• Agree not to participate in another interventional study while on treatment.
• If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from Screening, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 11.
• If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.

Exclusion Criteria:

• Induction therapy, other than study-assigned rATG, planned as part of initial immunosuppressive regimen.
• Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies.
• Currently treated with corticosteroids other than topical or inhaled corticosteroids.
• Previous treatment with tegoprubart.
• Previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi-organ or dual-kidney transplant.
• Will receive a kidney with an anticipated cold ischemia time of > 30 hours.
• Will receive a kidney from a donor that meets any of the following:
  • Donation after Cardiac Death (DCD) criteria; Or
  • Kidney Donor Profile Index (KDPI) of > 85%; Or
  • Is blood group (ABO) incompatible.
• History of any other acute or chronic medical condition, psychiatric disorder or preplanned medical/surgical procedure that, in the opinion of the Investigator, would compromise the safety of the patient or the integrity of study results.
• Medical conditions that require chronic use of systemic or other immunosuppressants.
• History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation.
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (HBV) surface antigen, or HBV core antibody, or Hepatitis C (HCV). For HCV, a positive HCV antibody test is exclusionary unless the recipient is known to have been treated for HCV, in which case HCV RNA can be measured, and the recipient would only be excluded if HCV RNA positive.
• Current calculated panel reactive antibody (cPRA) > 80%.
• Current malignancy or a history of malignancy (within the past 5 years), except nonmetastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
• Elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than 2 times the upper value of the normal range at screening.
• Current or history of active tuberculosis infection. Laboratory evidence of infection (positive PPD or QuantiFERON-TB Gold) in the absence of clinical infection is exclusionary unless the patient has completed CDC recommended treatment:
  • Participants with documented BCG vaccination and a negative chest x-ray may be included at the Investigator’s discretion.
• Concurrent participation in another interventional study or treatment with an investigational drug up to 30 days or 5 half-lives (depending on medication) prior to Screening.
• Treatment with an immunologic biologic compound (i.e., tumor necrosis factor inhibitors, [e.g., etanercept, adalimumab], intravenous immunoglobulin) within 90 days of Screening.
• Known hypersensitivity to tacrolimus, mycophenolate, rATG, corticosteroids, or any of their components.
• Active substance abuse within 1 year prior to Screening.
• Clinically significant abnormal ECG at Screening.
• Recipient is seronegative for EBV at Screening.
• Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening.
• Thrombocytopenia (platelets < 75,000 per mm^3 ), leukopenia (WBC < 3,000 per mm^3 ), or anemia (hemoglobin < 8 g/ dL) at Screening.
• Desensitization therapy within 6 months of transplant.
• Pregnancy or breastfeeding.
• Unlikely to comply with the visits scheduled in the protocol, in the opinion of the Investigator.
• Active COVID infection at the time of screening or a recent history of COVID infection within 30 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.