Effect of pegloticase on renal function in patients with chronic kidney disease: a post hoc subgroup analysis of 2 randomized, placebo-controlled, phase 3 clinical trials.

Published online

Journal Article

BACKGROUND: Pegloticase is approved in the US for treatment of refractory chronic gout. Since chronic kidney disease (CKD) is common in these patients, we conducted a post-hoc analysis of 2 replicate phase 3 trials and the subsequent open-label extension study to determine the effects of pegloticase on renal function in patients with CKD stages 3 and 4, as well as the effects of renal dysfunction on pegloticase efficacy and safety. FINDINGS: Patients with renal insufficiency were randomized to pegloticase 8 mg every 2 weeks (n = 42), pegloticase 8 mg every 4 weeks (n = 41), or placebo (n = 20) for 6 months as defined by the study protocols. Renal function was assessed by estimated glomerular filtration rate (eGFR). All patients completing the randomized trials could participate in an open-label extension study for a further 2.5 years. Uric acid response, the primary end point in the trials, was plasma uric acid <6.0 mg/dl for 80% of months 3 and 6.Mean eGFR in both pegloticase dosing cohorts remained constant over the randomized treatment phase and long-term open-label extension study. The number of patients achieving uric acid response was similar across CKD stages (32% stage 1, 23% stage 2, 35% stage 3, and 39% stage 4, respectively, P = 0.3). There was no difference in the pegloticase safety profile based on CKD stage. CONCLUSIONS: Pegloticase treatment does not impact eGFR in CKD patients and response to pegloticase is independent of CKD stage. TRIAL REGISTRATION: Clinical trial identifier: NCT00325195.

Full Text

Duke Authors

Cited Authors

  • Yood, RA; Ottery, FD; Irish, W; Wolfson, M

Published Date

  • January 21, 2014

Published In

Volume / Issue

  • 7 /

Start / End Page

  • 54 -

PubMed ID

  • 24447425

Pubmed Central ID

  • 24447425

Electronic International Standard Serial Number (EISSN)

  • 1756-0500

Digital Object Identifier (DOI)

  • 10.1186/1756-0500-7-54

Language

  • eng

Conference Location

  • England