Randomized multicentre pilot study of LCZ696 versus irbesartan in patients with chronic kidney disease: UK Heart And Renal Protection (HARP)-III

niversity of Oxford (UK)0 个研究点目标入组 400 人开始时间: 2014年1月20日最近更新: 2018年8月20日

适应症

试验速览

•Current inclusion criteria as of 03/05/2016:
•1. Men or women aged =18 years (at screening)
•2. Established proteinuric chronic kidney disease i.e. on measurements in the last 3 months:
•2.1. An estimated glomerular filtration rate =20 <45 mL/min/1.73m2 (estimated with Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) OR
•2.2. An estimated glomerular filtration rate =45 <60 mL/min/1.73m2 and albumin:creatinine ratio >20 mg/mmol (or protein:creatinine ratio >30 mg/mmol)
•Previous inclusion criteria:
•1. Men or women aged =18 years (at screening)
•2. Established proteinuric chronic kidney disease i.e. on measurements in the last 3 months:
•2.1. Estimated glomerular filtration rate (eGFR) =20 <60 mL/min/1.73m2 (estimated with Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology
•Collaboration [CKD-EPI] formula) AND
•2.2. Urine albumin:creatinine ratio =30 mg/mmol

•1. Angiotensin receptor blocker (ARB) therapy contraindicated e.g. bilateral renal artery stenosis
•2. Known intolerance of ARB
•3. Current treatment with aliskiren
•4. Mean systolic blood pressure >180 mmHg at screening visit (or investigator unwilling to withdraw angiotensin-converting enzyme inhibitors [ACEi], ARB or DRI for another reason)
•5. Serum potassium >5.5 mmol/L (updated 03/05/2016; previously >5.2 mmol/L)
•6. Presence of nephrotic syndrome (i.e. urine protein:creatinine ratio >350 mg/mmol [or albumin:creatinine ratio >300 mg/mmol] AND serum albumin <30 g/L) or currently receiving immunosuppression for nephrotic syndrome
•7. Functioning renal transplant
•8. Acute coronary syndrome, stroke or transient ischaemic attack in 3 months prior to Screening
•9. Known chronic liver disease or alanine aminotransferase/aspartate aminotransferase (ALT/AST) >2x upper limit normal (ULN) at screening
•10. History of angioedema (drug-related or otherwise)
•11. Use of unlicensed investigational medicinal product in previous month
•12. Pregnancy or women with child-bearing potential (refusing a reliable method of contraception3)
•13. Medical history that might limit the patient?s ability to take study treatments for the duration of the study (e.g. severe respiratory disease, or recent history of alcohol or substance misuse or history of cancer or evidence of spread in last 5 years other than non-melanoma skin cancer)

发起方

niversity of Oxford (UK)