hypertensie Chronic kidney disease chronic renal insufficiency
Conditions
Interventions
Patients will be randomized to receive sacubitril/valsartan (initial dosage 97
mg / 103 mg, once daily
final dosage 97 mg / 103 mg twice daily) or valsartan
(initial dosage 160 mg, once daily
final dosage 160 mg twice daily). Due to
higher biological availability, 160 mg valsartan is equipotent to 103 mg
valsartan in the combination drug. The study will last 14 weeks (2 week run-in
peri
Angiotensin Receptor/Neprilysin inhibitor (ARNI)
Hypertension
Nephropathy
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Age > 18 years * Chronic kidney disease stage 3 or 4 (eGFR 15-60 ml/min/1.73m2) * Residual proteinuria during RAAS blockade (* 1 g/day) * Diabetes mellitus type 2 * Hypertension (office systolic blood pressure > 140 mmHg OR use of any anti-hypertensive drug)
Exclusion criteria
Exclusion criteria: * SBP >180 mmHg at screening * Not possible to withdraw ACEi or ARB * Known intolerance or contraindication for ARB * History of angioedema * Nephrotic syndrome * Rapidly declining kidney function with high likelihood of dialysis or transplantation in the coming 4 months * Use of immunosuppressive drugs * Kidney transplant recipients * Pregnant or breastfeeding women * Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary endpoint is change in 24-hour proteinuria, compared between sacubitril/valsartan treatment and valsartan treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the effects on ambulatory blood pressure, eGFR, number of AEs and SAEs, parameters of kidney damage, renin-angiotensin-aldosterone system and natriuretic peptide system. | — |
Countries
The Netherlands
Outcome results
None listed