Chronic kidney disease and hyperuricaemia
Conditions
Interventions
Product Name: Verinurad 3mg
Product Code: RDEA3170
Pharmaceutical Form: Capsule
INN or Proposed INN: Verinurad
CAS Number: 1352792-74-5
Other descriptive name: RDEA3170
Concentration unit: mg milligra
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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. - Patients with CKD. CKD as defined in the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines as abnormalities in kidney structure or function present for >3 months; ie, there must be a documented occurrence at least 3 months before randomisation of either of the following eGFR =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: - Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [Wegener's granulomatosis], microscopic polyangiitis, or eosinophilic granulomatosis with polyangiitis [Churg-Strauss syndrome]). - History of renal transplantation - Known carrier of the (HLA-B) *58:01 allele. HLA-B *58:01 genotyping is mandatory prior to randomisation for all patients. - 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 - Evidence of significant liver disease (eg, aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >1.5x ULN). An isolated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion. - 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. - Dose of ACEi, ARBs, fenofibrate, guaifenesin, or SGLT2 inhibitors changed within 4 weeks of randomisation or further dose titration expected after randomisation - Treated with strong or moderate (OATP) inibitors - Participation in another clinical study with an investigational product administered during the last month prior to randomisation - Patients who are pregnant, lactating, or planning to become pregnant. ?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of treatment with verinurad and allopurinol, allopurinol alone, and placebo on UACR at 6 months;Secondary Objective: To assess the effects of treatment with verinurad and allopurinol, allopurinol alone, and placebo on UACR at 12 months To assess the effects of verinurad and allopurinol, allopurinol alone, and placebo on sUA To estimate the dose-response relationship among 3 doses of verinurad and allopurinol and placebo on UACR and sUA To assess the effects of verinurad and allopurinol versus placebo on kidney function.;Primary end point(s): Change from baseline in UACR at 6 months;Timepoint(s) of evaluation of this end point: From baseline at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in UACR at 12 months, end of treatment and end of study • Change from baseline in sUA at 6 and 12 months, end of treatment and end of study • Change from baseline in estimated glomerular filtration rate at 6 and 12 months, end of treatment and end of study • Change from baseline in creatinine at 6 and 12 months, end of treatment and end of study • Change from baseline in cystatin-C at 6 and 12 months end of treatment and end of study;Timepoint(s) of evaluation of this end point: • From baseline at 12 months, end of treatment and end of study • From baseline at 6 and 12 months, end of treatment and end of study • From baseline at 6 and 12 months, end of treatment and end of study • From baseline at 6 and 12 months, end of treatment and end of study • From baseline at 6 and 12 months, end of treatment and end of study | — |
Countries
Canada, Czechia, Czech Republic, France, Hungary, Israel, Italy, Mexico, Poland, Romania, Slovakia, South Africa, Spain, United States
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed