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

AstraZeneca AB0 sites725 target enrollmentJune 11, 2019

ConditionsChronic kidney disease and hyperuricaemia Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsAllopurinol

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic kidney disease and hyperuricaemia
Sponsor: AstraZeneca AB
Enrollment: 725
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 11, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•\- Provision of signed and dated, written ICF.
•\- Provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis
•\- Patient must be \=18 years of age at the time of signing the ICF.
•\- CKD as defined in the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines; ie, there must be a documented occurrence at least 3 months before randomisation of eGFR \<60 mL/min/1\.73 m2, UACR \=30 mg/g, and/or other markers of kidney damage (including urine protein dipstick \=1\+, positive urine albumin dipstick, or urinary protein to creatinine ratio \=84 mg/g)
•\- Patients should receive background standard of care treatment for albuminuria and/or T2DM and be treated according to locally recognised guidelines, as appropriate. Guideline\-recommended medications should be used at recommended doses. Therapy should have been optimised and stable for \=4 weeks before study entry and include an ACEi or an ARB, unless contraindicated, not tolerated, or in the opinion of the investigator not practically available or suitable.
•\- If treated with a sodium\-glucose transport protein (SGLT2\) inhibitor, the SGLT2 inhibitor dose must have been stable for \=4 weeks before randomisation.
•\- Meeting screening criteria for sUA and eGFR (Visit 2\)
•(a) sUA \=6\.0 mg/dL
•(b) eGFR \=25 mL/min/1\.73 m2 (CKD\-EPI formula)
•\- Mean UACR between 30 mg/g and 5000 mg/g inclusive. At least 2 first morning void samples collected before randomisation will be required.

Exclusion Criteria

•\- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti\-neutrophil cytoplasmic antibody (ANCA)\-associated vasculitis
•\- History of renal transplantation
•\- Known carrier of the (HLA\-B) \*58:01 allele.
•\- Patients diagnosed with tumor lysis syndrome or Lesch\-Nyhan syndrome
•\- History of stroke, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft in the past 6 months
•\- Uncontrolled hypertension presenting with systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>100 mm Hg
•\- Diagnosed with heart failure and (NYHA) Class IV at the time of randomisation
•\- QT interval corrected by the Fridericia formula (QTcF) \>470 msec; patients diagnosed with long QT syndrome; patients with a family history of long QT syndrome
•\- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
•\- Treated with any drug for hyperuricaemia in the 6 months preceding randomisation.