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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Amiloride; Diuretics; Hydrochlorothiazide

Criteria

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)