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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02875886

Acronym

Enrollment

Registered

2016-08-23

Start date

2016-09-30

Completion date

2018-04-30

Last updated

2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Brief 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.

Detailed 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.

Interventions

DRUGAmiloride

Combined with hydrochlorothiazide

DRUGHydrochlorothiazide

Combined with amiloride

OTHERLow-sodium diet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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)

Design outcomes

Primary

Measure	Time frame
24 hour blood pressure	Two weeks after start of each intervention

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026