DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease

Erasmus University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Amiloride; Other: Low-sodium diet; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT02875886

NL54748.078.15

Details and patient eligibility

About

In this clinical study the anti-hypertensive response to dietary salt restriction is compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult patients with chronic kidney disease.

Full description

Patients with chronic kidney disease (CKD) are exquisitely salt-sensitive. Salt-sensitivity in CKD is linked to hypertension and cardiovascular outcomes. Dietary salt restriction is an accepted intervention for salt-sensitivity in CKD. Another strategy, however, could be to block sodium uptake by the kidney pharmacologically by diuretics. Especially diuretics acting on the distal tubule may be effective, because this appears to be the site of increased sodium reabsorption in CKD. It is currently unknown how these two strategies, diet or diuretics, relate. The investigators hypothesize that diuretics are non-inferior to diet.

Enrollment: 28 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years.
• CKD 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)

Exclusion criteria

• Salt-wasting CKD
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Diuretic treatment

Active Comparator group

Description:

Patients receive amiloride and hydrochlorothiazide

Treatment:

Drug: Hydrochlorothiazide

Drug: Amiloride

Low-sodium diet

Active Comparator group

Description:

Patients are put on a low-sodium diet (60 mmol/day)

Treatment:

Other: Low-sodium diet