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

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02875886
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
19
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diuretic treatment

Patients receive amiloride and hydrochlorothiazide

Drug: Amiloride
Combined with hydrochlorothiazide

Drug: Hydrochlorothiazide
Combined with amiloride
Active Comparator: Low-sodium diet

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

Other: Low-sodium diet

Outcome Measures

Primary Outcome Measures

  1. 24 hour blood pressure [Two weeks after start of each intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 ErasmusMC Rotterdam Netherlands

Sponsors and Collaborators

  • Erasmus Medical Center

Investigators

  • Principal Investigator: Ewout J Hoorn, MD, PhD, Erasmus MC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ewout Hoorn, Internist nephrologist, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT02875886
Other Study ID Numbers:
  • NL54748.078.15
First Posted:
Aug 23, 2016
Last Update Posted:
Apr 20, 2018
Last Verified:
Apr 1, 2018
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hydrochlorothiazide
Amiloride

Study Results

No Results Posted as of Apr 20, 2018