The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.
Evidence shows independent associations between hyperuricaemia and the risk of hypertension, myocardial infarction, chronic kidney disease (CKD), type 2 diabetes, heart failure, and metabolic syndrome, including obesity Furthermore, gout, an inflammatory arthritis caused by deposition of monosodium urate crystals in joints, is associated with an increased risk of all-cause death, as well as cardiovascular (CV) death.
Hyperuricaemia is a prerequisite for development of gout, an inflammatory arthritis caused by deposition of monosodium urate crystals in joints. Gout occurs in patients with serum urate >6.8 mg/dL, which is the solubility limit of monosodium urate. The prevalence of gout increases with higher serum urate. However, the causal relationship between hyperuricaemia / gout and the aforementioned diseases and outcomes remains to be proven.
Verinurad is a novel uric acid transporter 1 (URAT1) inhibitor in Phase 2 development to increase uric acid (UA) excretion and thereby lower sUA levels. Verinurad combined with the xanthine oxidase inhibitor (XOI) febuxostat has been shown to lower UACR in patients with diabetes and albuminuria, and to lower serum uric acid (sUA) by >80% in patients with recurrent gout in Phase 2 studies.
UACR is a measurement of albuminuria, it was chosen because changes in UACR can be detected early in response to treatment, and these changes, if substantial, correlate with progression of CKD, deterioration in estimated glomerular filtration rate (eGFR), and hard outcomes.Therefore, change in UACR is regarded as an appropriate endpoint.
In this study, change in UACR at 6 months of treatment is the primary endpoint for the efficacy evaluation of treatment with the combination of verinurad and allopurinol vs. placebo.
A key secondary objective is evaluation of verinurad plus allopurinol on the reduction in UACR at 12 months.
Additional secondary endpoints include changes from baseline in sUA, eGFR, cystatin C, creatinine and N-terminal natriuretic peptide (NT-proBNP). Further, standard safety parameters such as adverse event (AEs), serious adverse event (SAEs), and laboratory evaluations will be employed to assess the safety profile of the study drugs.
Verinurad, allopurinol and oxypurinol plasma concentrations over time will also be measured.
This study will assess the effects of treatment with verinurad and allopurinol, allopurinol alone, and placebo on UACR at 6 months.
The study will recruit patients with Chronic Kidney Disease and Hyperuricaemia.
|Treatment||Allopurinol, Verinurad, Placebo for Verinurad, Placebo for Allopurinol|
|Clinical Study Identifier||NCT03990363|
|Last Modified on||1 July 2020|
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