Chronic kidney disease Urological and Genital Diseases Chronic kidney disease, unspecified
Conditions
Interventions
Current interventions as of 03/05/2016:
LCZ696: 200 mg orally once daily for 2 weeks then increased to 400 mg orally once daily for total duration 12 months.
Irbesartan: 150 mg orally once daily for
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/05/2016: Change in measured glomerular filtration rate from baseline to 12 months Previous primary outcome measures: Change in measured glomerular filtration rate from baseline to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/05/2016: 1. Urine albumin:creatinine ratio will be measured from baseline to 12 months 2. Pharmacokinetics will be measured at 3 months Previous secondary outcome measures: 1. Urine albumin:creatinine ratio will be measured from baseline to 6 months 2. Pharmacokinetics will be measured at 3 months | — |
Countries
United Kingdom
Outcome results
None listed