EUCTR2018-004079-11-ES进行中（未招募）1 期
A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricaemia - SAPPHIRE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 725
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 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.
- •- Male or female
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 425
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •- 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.
- •- 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.
研究者
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