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

Oxford Radcliffe Hospitals NHS Trust0 个研究点目标入组 400 人开始时间: 2014年7月28日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1. Age >=18 years.
•2. Estimated glomerular filtration rate (eGFR) >=20 and <45 mL/min/1.73m^2 OR
•3. eGFR >=45 and <60 mL/min/1.73m^2 AND Urine albumin:creatinine ratio (ACR) >=20 mg/mmol.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1. Angiotensin receptor blocker (ARB) therapy contraindicated.
•2. Known intolerance of ARB therapy.
•3. Current use of direct renin inhibitor aliskiren
•4. Systolic blood pressure >180 mmHg at Screening visit.
•5. Serum potassium >5.5 mmol/L at Screening visit.
•6. Presence of nephrotic syndrome (defined as ACR >300 mg/mmol and serum albumin <30 g/L) or receiving immunosuppression as treatment of nephrotic syndrome at Screening.
•7. Functioning renal transplant.
•8. Acute coronary syndrome, stroke or transient ischaemic attack in previous 3 months prior to Screening.
•9. Known chronic liver disease (or ALT >2x upper limit of normal at Screening).
•10. History of angioedema.
•11. Use of unlicensed medicinal product in previous month.
•12. Pregancy or women with child-bearing potential (refusing a reliable method of contraception).
•13. Other medical history that might limit the patient's ability to take study treatments for the duration of the study (eg, recent history of alcohol or substance misuse, severe respiratory disease).

发起方

Oxford Radcliffe Hospitals NHS Trust