Evidence map›Paper›PMID 34383954›Full record

ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2022

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.

Hiddo J L Heerspink, Austin G Stack, Robert Terkeltaub, Tom A Greene, Lesley A Inker, Magnus Bjursell, Shira Perl, Tord Rikte, Fredrik Erlandsson, Vlado Perkovic

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
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.

NCT03118739 phase2completednot on this map

Effects of Intensive Uric Acid Lowering Therapy With RDEA3170 (Verinurad) and Febuxostat in Patients With Albuminuria

TypeinterventionalSponsorAstraZenecaRan2017 to 2018Enrolled60ConditionsHyperuricemia, Albuminuria, Type 2 DiabetesArmsVerinurad 9 mg+Febuxostat 80 mg, Placebo
NCT03990363 phase2completednot on this map

A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia

TypeinterventionalSponsorAstraZenecaRan2019 to 2021Enrolled861ConditionsChronic Kidney DiseaseArmsVerinurad, Allopurinol, Placebo for Verinurad, Placebo for Allopurinol
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
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

10 authors at 8 institutions in 5 countries.

Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-3126-3730
Austin G StackSchool of Medicine & Health Research Institute, University of Limerick, Limerick, Ireland.
Robert TerkeltaubSan Francisco VA Health Care System, University of California San Diego, La Jolla, CA, USA.
Tom A GreeneUniversity of Utah School of Medicine, Salt Lake City, UT, USA.
Lesley A InkerTufts Medical Center, Boston, MA, USA.
Magnus BjursellAstraZeneca R&D Gothenburg, Mölndal, Sweden.
Shira PerlAstraZeneca R&D, Gaithersburg, MD, USA.
Tord RikteAstraZeneca R&D Gothenburg, Mölndal, Sweden.
Fredrik ErlandssonAstraZeneca R&D Gothenburg, Mölndal, Sweden.
Vlado PerkovicThe George Institute for Global Health, Sydney, Australia.ORCID 0000-0002-4257-7620
AstraZeneca (Sweden) · SEAstraZeneca (United States) · USThe George Institute for Global Health · AUTufts Medical Center · USUniversity Medical Center Groningen · NLUniversity of California San Diego · USUniversity of Limerick · IEUniversity of Utah · US

Funding

The Effects of Urate Lowering Therapy on Inflammation, Endothelial function, andP50AR060772 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, KENNETH G · 2012 to 2021
$12.8M
Novel Synovial Role in Pathogenesis of GoutR21AR075990 · NIAMS · VETERANS MEDICAL RESEARCH FDN/SAN DIEGO · PI TERKELTAUB, ROBERT A. · 2019 to 2020
$333k
NIAMS NIH HHS P50 AR060772NIAMS NIH HHS R21 AR075990
6 · The paper itself

Abstract

backgroundVerinurad is a human uric acid (UA) transporter (URAT1) inhibitor known to decrease serum UA (sUA) levels and that may reduce albuminuria. In a Phase 2a study (NCT03118739), treatment with verinurad + febuxostat lowered urine albumin-to-creatinine ratio (UACR) at 12 weeks by 39% (90% confidence interval 4-62%) among patients with Type 2 diabetes mellitus, hyperuricaemia and albuminuria. The Phase 2b, randomized, placebo-controlled Study of verinurAd and alloPurinol in Patients with cHronic kIdney disease and hyperuRicaEmia (SAPPHIRE; NCT03990363) will examine the effect of verinurad + allopurinol on albuminuria and estimated glomerular filtration rate (eGFR) slope among patients with chronic kidney disease (CKD) and hyperuricaemia.

methodsAdults (≥18 years of age) with CKD, eGFR ≥25 mL/min/1.73 m2, UACR 30-5000 mg/g and sUA ≥6.0 mg/dL will be enrolled. Approximately 725 patients will be randomized 1:1:1:1:1 to 12, 7.5 or 3 mg verinurad + allopurinol, allopurinol or placebo. An 8-week dose-titration period will precede a 12-month treatment period; verinurad dose will be increased to 24 mg at Month 9 in a subset of patients in the 3 mg verinurad + allopurinol arm. The primary efficacy endpoint the is change from baseline in UACR at 6 months. Secondary efficacy endpoints include changes in UACR, eGFR and sUA from baseline at 6 and 12 months.

conclusionsThis study will assess the combined clinical effect of verinurad + allopurinol on kidney function in patients with CKD, hyperuricaemia and albuminuria, and whether this combination confers renoprotection beyond standard-of-care.

Indexed as

Diabetes Mellitus, Type 2HyperuricemiaRenal Insufficiency, ChronicAdultAlbuminuriaAllopurinolAluminum OxideClinical Trials, Phase II as TopicDemographyGlomerular Filtration RateHumansNaphthalenesPropionatesPyridinesRandomized Controlled Trials as TopicAllopurinolAluminum OxideNaphthalenesPropionatesPyridinesverinuradchronic kidney diseasehyperuricaemiarandomized controlled clinical trialURAT1 inhibitorverinurad

Identifiers

PMID34383954
PMCPMC9317164
OpenAlexW3189925705

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.