Hypertension in chronic kidney disease
Conditions
Interventions
Trade Name: Moduretic
Product Name: Moduretic
Product Code: MSD 917
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years. - Chronic kidney disease stage 3 or 4 (MDRD-GFR 15-60 ml/min) - Use of any anti-hypertensive drugs - No anti-hypertensive drugs but an average office systolic blood pressure > 140 mmHg (as measured by datascope) 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Salt-wasting chronic kidney disease - Nephrotic syndrome - Pregnant or breastfeeding women - Life expectancy 5.0 mmol/l - Inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the anti-hypertensive response to dietary salt restriction with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in patients with chronic kidney disease stages 3 or 4. ;Secondary Objective: - To analyze the response in kidney parameters, the systemic and intra-renal renin-angiotensin system to the two interventions. - To compare the side-effects of the two interventions. ;Primary end point(s): The study ends after 8 weeks (in which participants recieve both amiloride/hydrochlorothiazide and placebo). The primary end point is 24 hour ambulatory blood pressure. ;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of AEs and SAEs. - Effects of the interventions on blood and urinary parameters (routine measurements, systemic and intrarenal renin-angiotensin-system, kidney injury markers, urinary exosomes) ;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Outcome results
None listed