Chronic Kidney DiseasePhase 4DDNCT02875886
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
A Phase 4 study testing Amiloride, Hydrochlorothiazide and Low-sodium diet in people with Chronic Kidney Disease, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Amiloride, Hydrochlorothiazide and Low-sodium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Amiloride, Hydrochlorothiazide, Low-sodium diet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmilorideDrug
Combined with hydrochlorothiazide
HydrochlorothiazideDrug
Combined with amiloride
Low-sodium dietOther
| Study group | Role | What they receive |
|---|---|---|
| Diuretic treatment | Active comparator | Patients receive amiloride and hydrochlorothiazide Receives: Drug: Amiloride; Drug: Hydrochlorothiazide |
| Low-sodium diet | Active comparator | Patients are put on a low-sodium diet (60 mmol/day) Receives: Other: Low-sodium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour blood pressure
Measured: Two weeks after start of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewout Hoorn, Erasmus Medical Center
- Investigators
- Ewout J Hoorn, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875886
- Sponsor's protocol ID
- NL54748.078.15
- Acronym
- DD
- Status last verified
- Apr 2018
- First submitted
- 18 Aug 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
Publications
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.
PubMed 24345270McMahon 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.
PubMed 25691262Agarwal 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.
PubMed 24526255Slagman 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.
PubMed 21784839Levy 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.
PubMed 18264941McMahon 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.
PubMed 34164803Bovee 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.
PubMed 31996411
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02875886
- Acronym / sponsor ID
- DD / NL54748.078.15
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diuretic treatment | Active comparator | Drug: Amiloride, Drug: HydrochlorothiazidePatients receive amiloride and hydrochlorothiazide |
| Low-sodium diet | Active comparator | Other: Low-sodium dietPatients are put on a low-sodium diet (60 mmol/day) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmilorideCombined with hydrochlorothiazide | Drug | Diuretic treatment |
| HydrochlorothiazideCombined with amiloride | Drug | Diuretic treatment |
| Low-sodium diet | Other | Low-sodium diet |
Primary outcome
24 hour blood pressure
Time frame: Two weeks after start of each intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Background: PubMed 24345270Meng 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.
- Background: PubMed 25691262McMahon 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.
- Background: PubMed 24526255Agarwal 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.
- Background: PubMed 21784839Slagman 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.
- Background: PubMed 18264941Levy 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.
- Derived from this study: PubMed 34164803McMahon 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.
- Derived from this study: PubMed 31996411Bovee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewout J Hoorn, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiloride, Hydrochlorothiazide and Low-sodium diet in people with Chronic Kidney Disease, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour blood pressure (time frame: Two weeks after start of each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875886, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.