Trial reportBMC research notes2014
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.
Trial report in BMC research notes, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00325195 (Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- 2024 Update of Chinese Guidelines for Management of Hyperuricemia and Gout Part II: Recommendations for Patients With Common Comorbidities.International journal of rheumatic diseases · 2025Guideline
- Prevention of kidney function decline using uric acid-lowering therapy in chronic kidney disease patients: a systematic review and network meta-analysis.Clinical rheumatology · 2022Pooled it
- Uric acid lowering therapies for preventing or delaying the progression of chronic kidney disease.The Cochrane database of systematic reviews · 2017Pooled it
- Effects of uric acid-lowering therapy in patients with chronic kidney disease: A meta-analysis.PloS one · 2017Pooled it
- Nucleotide Metabolism in Health and Disease.MedComm · 2026Review
- Urate-lowering therapy, serum urate, inflammatory biomarkers, and renal function in patients with gout following pegloticase discontinuation.Arthritis research & therapy · 2024Article
- Dysregulated gene expression of SUMO machinery components induces the resistance to anti-PD-1 immunotherapy in lung cancer by upregulating the death of peripheral blood lymphocytes.Frontiers in immunology · 2024Article
- Caring for Australians and New Zealanders With Kidney Impairment Guidelines: Rapid Development of Urate Lowering Therapy Guidelines for People With CKD.Kidney international reports · 2022Article
- Community Practice Experiences with a Variety of Immunomodulatory Agents Co-Administered with Pegloticase for the Treatment of Uncontrolled Gout.Rheumatology and therapy · 2022Article
- Enhancing the Response Rate to Recombinant Uricases in Patients with Gout.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Expert Opinion on Pegloticase with Concomitant Immunomodulatory Therapy in the Treatment of Uncontrolled Gout to Improve Efficacy, Safety, and Durability of Response.Current rheumatology reports · 2022Review
- Efficacy and safety of urate-lowering therapy in people with kidney impairment: a GCAN-initiated literature review.Rheumatology advances in practice · 2021Review
- Only Hyperuricemia with Crystalluria, but not Asymptomatic Hyperuricemia, Drives Progression of Chronic Kidney Disease.Journal of the American Society of Nephrology : JASN · 2020Article
- Reply to 'The case for evidence-based medicine for the association between hyperuricaemia and CKD'.Nature reviews. Nephrology · 2020Article
- Comparison of renoprotective effects of febuxostat and allopurinol in hyperuricemic patients with chronic kidney disease.International urology and nephrology · 2019Article
- Urate-lowering therapy: current options and future prospects for elderly patients with gout.Drugs & aging · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPegloticase 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.
findingsPatients 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.
conclusionsPegloticase treatment does not impact eGFR in CKD patients and response to pegloticase is independent of CKD stage.
trial registrationClinical trial identifier: NCT00325195.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.