Dual treatment for patients with chronic kidney disease, high blood pressure and diabetes.

ARNI-study: ARNI or ARB to arrest progression of nephropathy. - ARNI-study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000213-23-NL

Enrollment

Unknown

Registered

2017-03-01

Start date

2017-07-21

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease with concurrent hypertension and diabetes.

Interventions

Trade Name: Entresto Pharmaceutical Form: Tablet Trade Name: Valsartan Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

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) 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 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

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 < 6 months • Inability to adhere to study protocol (due to language, incapacitated subjects, subjects with intellectual disability)

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the antiproteinuric effect of sacubitril/valsartan and valsartan in patients with stage 3 or stage 4 CKD, with concurrent hypertension and diabetes.;Secondary Objective: To compare the effects on ambulatory blood pressure, eGFR, number of AEs and SAEs, parameters of kidney damage, renin-angiotensin-aldosterone system and natriuretic peptide system.;Primary end point(s): To compare the reduction in 24-hour proteinuria of sacubitril/valsartan or valsartan in patients with stage 3 or stage 4 CKD, with concurrent hypertension and diabetes.;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: To compare the antiproteinuric effect of sacubitril/valsartan and valsartan in patients with stage 3 or stage 4 CKD, with concurrent hypertension and diabetes.;Secondary Objective: To compare the effects on ambulatory blood pressure, eGFR, number of AEs and SAEs, parameters of kidney damage, renin-angiotensin-aldosterone system and natriuretic peptide system.;Primary end point(s): To compare the reduction in 24-hour proteinuria of sacubitril/valsartan or valsartan in patients with stage 3 or stage 4 CKD, with concurrent hypertension and diabetes.;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Effects on ambulatory blood pressure, eGFR, number of AEs and SAEs, parameters of kidney damage, renin-angiotensin-aldosterone system and natriuretic peptide system.;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026