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

April 19, 2018 updated by: Ewout Hoorn, Erasmus Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour blood pressure
Time Frame: Two weeks after start of each intervention
Two weeks after start of each intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Ewout J Hoorn, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL54748.078.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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