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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diuretic treatment

Patients receive amiloride and hydrochlorothiazide

Group Type ACTIVE_COMPARATOR

Amiloride

Intervention Type DRUG

Combined with hydrochlorothiazide

Hydrochlorothiazide

Intervention Type DRUG

Combined with amiloride

Low-sodium diet

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

Group Type ACTIVE_COMPARATOR

Low-sodium diet

Intervention Type OTHER

Interventions

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Amiloride

Combined with hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide

Combined with amiloride

Intervention Type DRUG

Low-sodium diet

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No