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

NCT02875886 | Completed Phase 4

• 1 other identifier: NL54748.078.15
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 24 hour blood pressure

  Two weeks after start of each intervention

Study Arms (2)

Diuretic treatment

ACTIVE COMPARATOR

Patients receive amiloride and hydrochlorothiazide

Drug: Amiloride; Drug: Hydrochlorothiazide

Low-sodium diet

ACTIVE COMPARATOR

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

Other: Low-sodium diet

Interventions

Amiloride DRUG

Combined with hydrochlorothiazide

Diuretic treatment

Hydrochlorothiazide DRUG

Combined with amiloride

Diuretic treatment

Low-sodium diet OTHER

Low-sodium diet

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 24345270 BACKGROUND

• 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.

  PMID: 25691262 BACKGROUND

• 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.

  PMID: 24526255 BACKGROUND

• 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.

  PMID: 21784839 BACKGROUND

• 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.

  PMID: 18264941 BACKGROUND

• 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.

  PMID: 34164803 DERIVED

• 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.

  PMID: 31996411 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Amiloride; Hydrochlorothiazide; Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ewout J Hoorn, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internist nephrologist

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

NL (1)