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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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