Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant

Inclusion Criteria

• Willing and able to give informed consent;
• Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study;
• Adult men or women ≥ 18 years of age;
• Is a recipient of a de novo kidney from a living or deceased donor and is >1 year post transplant prior to screening;
• Is on a stable standard of care immunosuppression therapy for at least 3 months prior to screening;
• Kidney allograft is functional at entry, based on an estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73m²;
• Women of childbearing potential have a negative screening serum pregnancy test and will be required to use a medically approved form of birth control during their participation in the study;
• Uncontrolled gout, defined as:
• Hyperuricemia during screening as documented by sUA ≥ 7 mg/dL during Screening and prior to entry into the Treatment Period (Note: the sUA may be repeated up to 3 times during the Screening Period to confirm eligibility), and
• Inability to maintain sUA 160/100 mm Hg) at the end of the Screening Period (Day 1 prior to infusion);
• Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner, or not using an effective form of birth control, as determined by the Investigator;
• Prior treatment with pegloticase, another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug;
• Known allergy to pegylated products or history of anaphylactic reaction to a recombinant protein or porcine product;
• Receipt of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1, or plans to take an investigational drug during the study;
• Currently receiving systemic or radiologic treatment for ongoing cancer;
• History of malignancy within 5 years other than non-melanoma skin cancer, in situ carcinoma of cervix, early stage renal cell cancer or early stage prostate cancer that has been completely resected > 2 years prior to screening;
• Uncontrolled hyperglycemia with a plasma glucose value > 240 mg/dL at Screening that is not subsequently controlled by the end of the Screening Period;
• Diagnosis of osteomyelitis;
• Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome;
• Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study;
• Currently receiving allopurinol, febuxostat or other urate lowering medications and unable to discontinue medication 7 days prior to Day 1; or
• Currently receiving probenecid and unable to discontinue medication within 3 days, prior to Day 1.