Table 1.
Key inclusion and exclusion criteria in SAPPHIRE
| Inclusion | Criteria |
|---|---|
| Pre-screening | sUA ≥6 mg/dL, and |
| eGFR ≥25 mL/min/1.73 m2, and | |
| UACR ≥30 mg/g and ≤5000 mg/g | |
| Patient characteristics | Male or female |
| ≥18 years of age | |
| Disease characteristics | Documented CKD, defined by KDIGO guidelines as abnormalities in kidney structure or function present for >3 months: occurrence ≥3 months before randomization of either eGFR <60 mL/min/1.73 m2, UACR ≥30 mg/g and/or ≥1 other markers of kidney damage (including abnormalities detected by histology or imaging, urine sediments, urine protein dipstick ≥1+, positive urine albumin dipstick or urinary protein to creatinine ratio ≥84 mg/g) |
| Medication | Background standard-of-care treatment for CKD and/or T2DM in accordance with locally recognized guidelines, as appropriate |
| Therapy should have been optimized 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 an SGLT2 inhibitor, the dose must have been stable for ≥4 weeks before randomization | |
| Pregnancy | Negative pregnancy test at investigation site (urine or serum) for female patients of childbearing potential |
| Exclusion | Criteria |
| Medical conditions | Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis, or anti-neutrophil cytoplasmic antibody-associated vasculitis |
| Carrier of the Human Leukocyte Antigen-B *58:01 allele | |
| History of kidney transplantation | |
| History of stroke, myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft in the past 6 months | |
| Uncontrolled hypertension presenting with systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg | |
| Evidence of significant liver diseasea | |
| Medication | Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary kidney disease within 6 months prior to enrolment |
| Treatment with any drug for hyperuricaemia in the past 6 months | |
| Treated with strong or moderate OATP inhibitors |
a
For example, aspartate transaminase or alanine transaminase >3× ULN; or total bilirubin >1.5× ULN.
OATP, organic anion transporting polypeptide; ULN, the upper limit of normal.