Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)

Exclusion Criteria

• •Recipient of a multi-organ transplant.
• •History of T-cell mediated rejection (TCMR) within 3 months prior to randomization.
• •Patients who are receiving high dose corticosteroids at the time of screening.
• •Histologic evidence of acute TCMR (≥ Banff Grade 1A) on a qualifying renal biopsy for this study. Patients with 'borderline' changes (Banff criteria) on a qualifying renal biopsy are eligible for this study if the Principal Investigator believes treatment for TCMR is not warranted.
• •Prior or current histologic evidence of polyomavirus BK virus nephropathy.
• •Any histologic finding on the qualifying renal biopsy that the Investigator believes warrants modifying the patient's current therapy.
• •Evidence of active tissue invasive cytomegalovirus or Epstein-Barr virus infection.
• •History of malignancy, including carcinoma or post-transplant lymphoproliferative disorder.
• •History of chronic pulmonary disease or smoker within the past 5 years or more than 15 pack-years exposure.
• •Serious local infection or systemic infection within 3 months prior to screening.
• •Surgery within 3 months prior to Day 1 (other than minor cosmetic surgery, minor dental procedures, or percutaneous kidney transplant biopsy).
• •Positive test for HBsAg, HCV, or HIV antibody at screening.
• •Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month prior to dosing.