High Dose (mg) (verinurad/allopurinol) Step 1 - titration_ 3/100 Step 2 - titration_ 7.5/200 Step 3 - target dose_ 12/300

Intermediate Dose (mg) verinurad/allopurinol Step 1 - titration_ 3/100 Step 2 - titration_ 7.5/200 Step 3 - target dose_ 7.5/300

Low Dose (mg) verinurad/allopurinol Step 1 - titration_3/100 Step 2 - titration_3/200 Step 3 - target dose_3/300

Step 1 - titration_0/100 Step 2 - titration_0/200 Step 3 - target dose_0/300

Chronic Kidney Disease

Study treatments will be titrated in 3 steps for target low dose (3 mg), intermediate dose ( 7.5 mg) and High Dose (12 mg) Verinurad.

Verinurad

Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol

Allopurinol

Placebo for Verinurad

Placebo for Allopurinol

Research Site

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

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

urinary albumin to creatinine ratio (UACR).

Change from baseline in estimated glomerular filtration rate

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

AstraZeneca

Blood for DNA isolation (no sequencing, only SNP array) Stool for microbiome analysis Saliva for microbiome analysis Plasma and serum for metabolomics Urine for creatinine analysis

HIV Infections

Onze Lieve Vrouwe Gasthuis

Radboudumc

Erasmus MC

Elisabeth Twee-Steden ziekenhuis

2000 HIV Human Functional Genomics Partnership Program

Change in liver fibrosis measurement by FibroScan (method by Echosens)

Change in liver steatosis measurement by FibroScan (method by Echosens) and liver ultrasound (method developed by Radboudumc)

Recoring of cadiovascular diseases from patient file:
Stroke/ TIA
Angina pectoris
Myocardial infarction
Claudicatio intermittens
Venous thrombo-embolism
Other …

Genome-wide genotype data including >8 million SNPs per individual

Colonizing microbiome profile will be generated from stool and saliva samples

RNA-sequencing will be performed in PBMCs

Metabolomics analysis by multiplex immunoassays will be performed in plasma or serum

Ex vivo cytokine responses of isolated PBMCs to a range of stimuli (TLR ligands, killed pathogens and viral antigen stimuli)

Extensive phenotyping of circulating immune cells by flow cytometry analysis

Note changes in ECG performed at baseline and two years

Ultrasound measurement of intima-media thickness in the carotid artery as a measure for atherosclerosis and cardiovasculr disease risk.

Radboud University

ViiV Healthcare

Elisabeth-TweeSteden Ziekenhuis

Erasmus Medical Center

Topiroxostat, (Oral daily dosing for 28 weeks)

Placebo, (Oral daily dosing for 28 weeks)

Diabetic Nephropathy

The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.

Topiroxostat BID, (Oral daily dosing for 28 weeks)

Subjects randomized to the placebo arm will receive placebo.

Placebo BID, (Oral daily dosing for 28 weeks)

Sanwa Kagaku Kenkyusho Co., Ltd.

Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout

Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).

gout/albumin

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

2000 HIV Human Functional Genomics Partnership Program

Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout

Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

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