Pegloticase in Kidney Transplant Patients with Uncontrolled Gout

Study Overview

A multicenter, open-label study evaluating the efficacy and safety of pegloticase (KRYSTEXXA) in adults with chronic gout refractory to conventional urate-lowering therapy who have undergone kidney transplantation. The primary endpoint is sustained serum uric acid reduction to <6 mg/dL during Month 6.

Inclusion Criteria

• ✓Adults aged 18 years or older with kidney transplant (>1 year post-transplant)
• ✓Serum uric acid ≥7 mg/dL at screening
• ✓Evidence of tophaceous deposits, recurrent flares (≥2 in past 12 months), or chronic gouty arthritis
• ✓Stable immunosuppression therapy for at least 3 months

Exclusion Criteria

• ✗G6PD deficiency
• ✗Prior treatment with pegloticase or another recombinant uricase
• ✗Organ transplant other than kidney
• ✗Uncontrolled blood pressure (>160/100 mmHg) or decompensated heart failure