Evidence map›Paper›PMID 29657831›Full record

ArticleRMD open2018

Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study.

Roy Fleischmann, Peter Winkle, Jesse Hall, Shakti Valdez, Sha Liu, Xiaohong Yan, Liz Hicks, Caroline Lee, Jeffrey N Miner, Michael Gillen and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in RMD open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02246673 (A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT02246673 phase2completednot on this map

A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout

TypeinterventionalSponsorArdea Biosciences, Inc.Ran2014 to 2016Enrolled64ConditionsGoutArmsRDEA3170 15 mg, RDEA3170 10 mg, RDEA3170 2.5, RDEA3170 5 mg, Febuxostat 40 mg
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Trial
  4. Trial
  5. Review
  6. Review
  7. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Article
  8. Article
  9. Review
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Roy FleischmannSouthwestern Medical Center, Metroplex Clinical Research Center, University of Texas, Dallas, Texas, USA.ORCID 0000-0002-6630-1477
Peter WinkleAnaheim Clinical Trials, Anaheim, California, USA.
Jesse HallArdea Biosciences, Inc., San Diego, California, USA.
Shakti ValdezArdea Biosciences, Inc., San Diego, California, USA.
Sha LiuArdea Biosciences, Inc., San Diego, California, USA.
Xiaohong YanArdea Biosciences, Inc., San Diego, California, USA.
Liz HicksArdea Biosciences, Inc., San Diego, California, USA.
Caroline LeeArdea Biosciences, Inc., San Diego, California, USA.
Jeffrey N MinerArdea Biosciences, Inc., San Diego, California, USA.
Michael GillenAstraZeneca LP, Gaithersburg, Maryland, USA.
Martha Hernandez-IllasQPS MRA (Miami Clinical Research), Miami, Florida, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveVerinurad (RDEA3170) is a high-affinity, selective URAT1 inhibitor in development for treating gout and asymptomatic hyperuricaemia. This study evaluated the pharmacodynamics, pharmacokinetics and safety of verinurad in combination with febuxostat in adults with gout.

methodsThe phase IIa, open-label, multicentre study randomised 64 subjects into one of five cohorts to receive febuxostat (40 or 80 mg) alone or in combination with verinurad 2.5-20 mg. Serial plasma/serum and urine samples were assayed for verinurad and uric acid. Safety was assessed by adverse events, chemistry panels, ECGs and physical examinations.

resultsSerum pharmacodynamic data demonstrated the maximum percent decrease in serum urate (sUA) from baseline (E

conclusionVerinurad administered with febuxostat produced dose-dependent decreases in sUA while maintaining urinary uric acid levels comparable to baseline. These dose combinations of verinurad and febuxostat were generally well tolerated. These data support continued investigation of oral verinurad in patients with gout. TRIAL REGISTRATION NUMBER: NCT02246673.

Indexed as

febuxostatgoutverinurad

Identifiers

PMID29657831
PMCPMC5892780

What OpenQuestion holds

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LicenceCC BY-NC
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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.