Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
Condition: Hyperuricemia; Albuminuria; Type 2 Diabetes
MeSH terms: Albuminuria; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to evaluate signals of potential clinical
      benefit of the combination of Verinurad and Febuxostat in lowering concentrations of
      circulating uric acid and thus improving kidney or cardiovascular status of patients with
      hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).
    

Detailed description: 
      Evidence shows independent associations between elevated serum uric acid (sUA) and the risk
      of hypertension, myocardial infarction (MI), chronic kidney disease (CKD), T2DM, heart
      failure (HF), and metabolic syndrome, including obesity. Gout is associated with an increased
      risk of all-cause death, as well as cardiovascular death. The causal relationship between
      elevated sUA, gout, and these disease outcomes remains to be proven.

      Verinurad (RDEA3170), is a novel Urate Transporter 1 (URAT1) inhibitor in Phase II
      development. Verinurad combined with the xanthine oxidase (XO) inhibitor febuxostat has been
      shown to lower sUA in patients with recurrent gout in Phase II studies by >80%. The extensive
      lowering of sUA delivered by the combination presents a unique opportunity to explore whether
      intensive urate lowering therapy can improve kidney and/or cardiac health.

      This study will assess if intensive serum urate lowering therapy, more potent than ever
      explored before in the chronic out-patient setting, can improve chronic kidney or cardiac
      function in the study population.

      In order to maximize the scientific value of the study and minimize the risk for systemic
      biases a parallel group, double blind, randomized design will be utilized.

      The study will recruit patients with hyperuricemia and presenting with albuminuria.

      Hyperuricemic patients are expected to benefit more from urate lowering, and albuminuria at
      baseline is required, as the primary objective of the study will be to assess changes in
      albuminuria.

      Patients are also required to be diagnosed with T2DM. Patients with T2DM frequently exhibit
      changes in cardiac function detectable using magnetic resonance imaging (MRI) that represents
      an early, pre-symptomatic state of HF. By limiting recruitment to patients with T2DM and by
      performing MRI at baseline and 6 months of therapy, the study will deliver insights into
      whether or not intensive urate lowering therapy can positively affect not only chronic kidney
      disease, but also cardiac disease.
    

Intervention name(s): Verinurad 9 mg+Febuxostat 80 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule administered orally, once daily for 24 weeks; Capsule administered orally, once daily for 24 weeks
Other intervention name(s): Verinurad (RDEA3170), Febuxostat(Uloric)
Intervention MeSH terms: Febuxostat; Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, double-dummy, placebo-controlled, parallel, independent groups, repeated measures, multi-center study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment