Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia
| Autor: | Lesley A. Inker, Hiddo J.L. Heerspink, Tord Rikte, Shira Perl, Sapphire investigators, Tom Greene, Vlado Perkovic, Magnus K. Bjursell, Fredrik Erlandsson, Robert Terkeltaub, Austin G. Stack |
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| Přispěvatelé: | Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Groningen Kidney Center (GKC) |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
verinu
Pyridines FOS: Health sciences chemistry.chemical_compound verinurad URAT1 inhibitor Aluminum Oxide Randomized Controlled Trials as Topic randomized controlled clinical trial OUTCOMES DEATH Nephrology TRIAL Febuxostat CANAGLIFLOZIN medicine.symptom Glomerular Filtration Rate medicine.drug Adult medicine.medical_specialty Allopurinol Urology Renal function Hyperuricemia URIC-ACID Naphthalenes Placebo Clinical Trials Phase II as Topic hyperuricaemia medicine CKD Albuminuria Humans Renal Insufficiency Chronic Demography Transplantation 42 Health sciences business.industry Type 2 Diabetes Mellitus Health sciences medicine.disease LIFE Diabetes Mellitus Type 2 chemistry Uric acid MEDIATORS Propionates business chronic kidney disease Kidney disease |
| Zdroj: | Nephrology Dialysis Transplantation, 37(8), 1461-1471. Oxford University Press |
| ISSN: | 0931-0509 |
| Popis: | Background Verinurad is a human uric acid (UA) transporter (URAT1) inhibitor known to decrease serum UA (sUA) levels and that may reduce albuminuria. In a Phase 2a study (NCT03118739), treatment with verinurad + febuxostat lowered urine albumin-to-creatinine ratio (UACR) at 12 weeks by 39% (90% confidence interval 4–62%) among patients with Type 2 diabetes mellitus, hyperuricaemia and albuminuria. The Phase 2b, randomized, placebo-controlled Study of verinurAd and alloPurinol in Patients with cHronic kIdney disease and hyperuRicaEmia (SAPPHIRE; NCT03990363) will examine the effect of verinurad + allopurinol on albuminuria and estimated glomerular filtration rate (eGFR) slope among patients with chronic kidney disease (CKD) and hyperuricaemia. Methods Adults (≥18 years of age) with CKD, eGFR ≥25 mL/min/1.73 m2, UACR 30–5000 mg/g and sUA ≥6.0 mg/dL will be enrolled. Approximately 725 patients will be randomized 1:1:1:1:1 to 12, 7.5 or 3 mg verinurad + allopurinol, allopurinol or placebo. An 8-week dose-titration period will precede a 12-month treatment period; verinurad dose will be increased to 24 mg at Month 9 in a subset of patients in the 3 mg verinurad + allopurinol arm. The primary efficacy endpoint the is change from baseline in UACR at 6 months. Secondary efficacy endpoints include changes in UACR, eGFR and sUA from baseline at 6 and 12 months. Conclusions This study will assess the combined clinical effect of verinurad + allopurinol on kidney function in patients with CKD, hyperuricaemia and albuminuria, and whether this combination confers renoprotection beyond standard-of-care. |
| Databáze: | OpenAIRE |
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