Salt restriction or water pills for hypertension in chronic renal disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

- Salt-wasting chronic kidney disease
- Nephrotic syndrome
- Pregnant or breastfeeding women
- Life expectancy < 6 months
- Severe heart failure (NYHA III or IV) or liver cirrhosis with ascites and the inability to withdraw diuretics
- Rapidly declining kidney function with high likelihood of dialysis or kidney transplantation in the coming 4 months
- Kidney transplant recipients
- Use of immunosuppressive drugs
- Use of non-steroidal anti-inflammatory drugs
- Previous intolerance or allergy to hydrochlorothiazide or amiloride
- Serum sodium < 135 mmol/l
- Serum potassium < 3.5 mmol/l or > 5.0 mmol/l
- Inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>- To compare the side-effects of the two interventions.<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of AEs and SAEs.<br>- Effects of the interventions on blood and urinary parameters (routine measurements, systemic and intrarenal renin-angiotensin-system, kidney injury markers, urinary exosomes)<br>;Timepoint(s) of evaluation of this end point: Not applicable.