UMMS Affiliation
Meyers Primary Care Institute
Publication Date
2014-01-21
Document Type
Article
Disciplines
Female Urogenital Diseases and Pregnancy Complications | Male Urogenital Diseases | Nephrology | Organic Chemicals | Therapeutics
Abstract
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.
Rights and Permissions
Copyright © 2014 Yood et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI of Published Version
10.1186/1756-0500-7-54
Source
BMC Res Notes. 2014 Jan 21;7:54. doi: 10.1186/1756-0500-7-54. Link to article on publisher's site
Journal/Book/Conference Title
BMC research notes
Related Resources
PubMed ID
24447425
Repository Citation
Yood RA, Ottery FD, Irish W, Wolfson M. (2014). 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. Meyers Health Care Institute Publications. https://doi.org/10.1186/1756-0500-7-54. Retrieved from https://escholarship.umassmed.edu/meyers_pp/703
Included in
Female Urogenital Diseases and Pregnancy Complications Commons, Male Urogenital Diseases Commons, Nephrology Commons, Organic Chemicals Commons, Therapeutics Commons