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

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ClinicalTrials.gov Identifier: NCT02875886
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ewout Hoorn, Erasmus Medical Center

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
Chronic Kidney Disease Drug: Amiloride Drug: Hydrochlorothiazide Other: Low-sodium diet 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 24 hour blood pressure [ Time Frame: Two weeks after start of each intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875886


Locations
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Netherlands
ErasmusMC
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Ewout J Hoorn, MD, PhD Erasmus MC

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ewout Hoorn, Internist nephrologist, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02875886    
Other Study ID Numbers: NL54748.078.15
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Hydrochlorothiazide
Amiloride
Diuretics
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing