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

Chronic Kidney Disease Clinical Trial

— DD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875886
• Other study ID #: NL54748.078.15
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2016
• Last updated: April 19, 2018
• Start date: September 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Amiloride
Combined with hydrochlorothiazide
• Hydrochlorothiazide
Combined with amiloride

Other:
• Low-sodium diet

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

Levy Yeyati N, Fellet A, Arranz C, Balaszczuk AM, Adrogué HJ. Amiloride-sensitive and amiloride-insensitive kaliuresis in advanced chronic kidney disease. J Nephrol. 2008 Jan-Feb;21(1):93-8. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood pressure		Two weeks after start of each intervention