EUCTR2018-004079-11-IT
Active, not recruiting
Phase 1
A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricaemia - SAPPHIRE
ConditionsChronic kidney disease and hyperuricaemiaMedDRA version: 20.0Level: HLTClassification code 10018067Term: General nutritional disorders NECSystem Organ Class: 100000004861Therapeutic 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
- 861
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 anARB, 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)
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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