A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia

    Not Recruiting
  • End date
    Sep 13, 2021
  • participants needed
  • sponsor
Updated on 19 May 2021
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (4.2 mi away) Contact
+226 other location
ace inhibitor
angiotensin converting enzyme


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.

Condition chronic renal insufficiency, Chronic renal failure, chronic kidney disease, chronic kidney disease (ckd)
Treatment Allopurinol, Verinurad, Placebo for Verinurad, Placebo for Allopurinol
Clinical Study IdentifierNCT03990363
Last Modified on19 May 2021

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note