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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Amiloride
Hydrochlorothiazide
Low-sodium diet
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • ErasmusMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diuretic treatment

Low-sodium diet

Arm Description

Patients receive amiloride and hydrochlorothiazide

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

Outcomes

Primary Outcome Measures

24 hour blood pressure

Secondary Outcome Measures

Full Information

First Posted
August 18, 2016
Last Updated
April 19, 2018
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02875886
Brief Title
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
Acronym
DD
Official Title
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diuretic treatment
Arm Type
Active Comparator
Arm Description
Patients receive amiloride and hydrochlorothiazide
Arm Title
Low-sodium diet
Arm Type
Active Comparator
Arm Description
Patients are put on a low-sodium diet (60 mmol/day)
Intervention Type
Drug
Intervention Name(s)
Amiloride
Intervention Description
Combined with hydrochlorothiazide
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
Combined with amiloride
Intervention Type
Other
Intervention Name(s)
Low-sodium diet
Primary Outcome Measure Information:
Title
24 hour blood pressure
Time Frame
Two weeks after start of each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewout J Hoorn, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ErasmusMC
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24345270
Citation
Meng L, Fu B, Zhang T, Han Z, Yang M. Salt sensitivity of blood pressure in non-dialysis patients with chronic kidney disease. Ren Fail. 2014 Apr;36(3):345-50. doi: 10.3109/0886022X.2013.866008. Epub 2013 Dec 17.
Results Reference
background
PubMed Identifier
25691262
Citation
McMahon EJ, Campbell KL, Bauer JD, Mudge DW. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD010070. doi: 10.1002/14651858.CD010070.pub2.
Results Reference
background
PubMed Identifier
24526255
Citation
Agarwal R, Sinha AD, Pappas MK, Ammous F. Chlorthalidone for poorly controlled hypertension in chronic kidney disease: an interventional pilot study. Am J Nephrol. 2014;39(2):171-82. doi: 10.1159/000358603. Epub 2014 Feb 11.
Results Reference
background
PubMed Identifier
21784839
Citation
Slagman MC, Nguyen TQ, Waanders F, Vogt L, Hemmelder MH, Laverman GD, Goldschmeding R, Navis G. Effects of antiproteinuric intervention on elevated connective tissue growth factor (CTGF/CCN-2) plasma and urine levels in nondiabetic nephropathy. Clin J Am Soc Nephrol. 2011 Aug;6(8):1845-50. doi: 10.2215/CJN.08190910. Epub 2011 Jul 22.
Results Reference
background
PubMed Identifier
18264941
Citation
Levy Yeyati N, Fellet A, Arranz C, Balaszczuk AM, Adrogue HJ. Amiloride-sensitive and amiloride-insensitive kaliuresis in advanced chronic kidney disease. J Nephrol. 2008 Jan-Feb;21(1):93-8.
Results Reference
background
PubMed Identifier
34164803
Citation
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
Results Reference
derived
PubMed Identifier
31996411
Citation
Bovee DM, Visser WJ, Middel I, De Mik-van Egmond A, Greupink R, Masereeuw R, Russel FGM, Danser AHJ, Zietse R, Hoorn EJ. A Randomized Trial of Distal Diuretics versus Dietary Sodium Restriction for Hypertension in Chronic Kidney Disease. J Am Soc Nephrol. 2020 Mar;31(3):650-662. doi: 10.1681/ASN.2019090905. Epub 2020 Jan 29.
Results Reference
derived

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

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