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

BMC Research Notes

Marsha Wolfson³  William Irish²  Faith D Ottery³  Robert A Yood¹ 

[1] Reliant Medical Group, 425 North Lake Ave., Worcester, MA 01605, USA;CTI Clinical Trial and Consulting Services, 8380 Six Forks Road, Suite 203, Raleigh, NC 27615, USA;Savient Pharmaceuticals Inc., 400 Crossing Boulevard, 3rd Floor, Bridgewater, NJ 08807, USA

关键词: Renal function;    Kidney;    Uric acid;    Refractory chronic gout;   

Others  :  1134740
DOI  :  10.1186/1756-0500-7-54

 received in 2013-07-26, accepted in 2014-01-03,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Yood et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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