The Role of Skin Sodium Accumulation in Chronic Kidney Disease
NCT ID: NCT07020104
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-01-07
2039-12-01
Brief Summary
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The main objective of the cohort study (A) is to investigate the prognostic implications of tissue sodium accumulation in CKD patients. The primary objective of the sodium intervention studies is to study the effect of high and low sodium intake (B) and increased renal sodium excretion (C) on tissue sodium content. The main objective of the water intervention study (D) is to investigate the effect of increased and habitual water intake on tissue sodium content and transepidermal water loss.
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Detailed Description
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60 CKD patients (eGFR 15 - 60 ml/min/1.73m2) are included in this cohort study. At the start of the study the association between tissue sodium content and micro-and macrovascular function will be evaluated. These patients will be followed up to investigate the association between tissue sodium content, quality of life and renal and cardiovascular events.
Sodium intake intervention (B):
A subgroup of 14 CKD patients (eGFR 15 - 60 ml/min/1.73m2) will be randomized to a 2-week low sodium diet and a 2-week high sodium diet in a cross-over study.
Sodium excretion intervention (C):
A subgroup of 12 CKD patients (eGFR 30 - 60 ml/min/1.73m2) with hypertension will be randomized to receive 6 weeks of treatment with hydrochlorothiazide, spironolactone and lercanidipine in a randomized open-label cross-over trial.
Water intake intervention (D) A subgroup of 12 CKD patients (with eGFR 15-30 ml/min/1.73m2, hypertension and fasting morning urine osmolality \< 425 mOsm/kg for men and \< 400 mOsm/kg for women) will be randomized to a 4-week habitual water intake and 4-week increased water intake in a cross-over study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
14 of the 60 CKD patients will be randomized to a 2-week low sodium diet and a 2-week high sodium diet in an open-label cross-over manner (B).
12 CKD patients will receive 3 antihypertensive agents (spironolactone, lercanidipine and hydrochlorothiazide) in random order for 6 weeks (C).
12 of the 60 CKD subjects will be randomized to a 4 week increased water intake and 4 week habitual water intake (D).
All the intervention mentioned above are separated by a washout period of at least 2 weeks between interventions.
OTHER
NONE
Study Groups
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Sodium excretion intervention (C)
In this intervention group, the patients will receive three antihypertensive drugs in a randomized order. Thus the following orders are possible:
1. Lercanidipine - Spironolactone - Hydrochlorothiazide
2. Lercanidipine - Hydrochlorothiazide - Spironolactone
3. Hydrochlorothiazide - Lercanidipine - Spironolactone
4. Hydrochlorothiazide - Spironolactone - Lercanidipine
5. Spironolactone - Lercanidipine - Hydrochlorothiazide
6. Spironolactone - Hydrochlorothiazide- Lercanidipine
Hydrochlorothiazide
Each patient will receive 1 tablet of hydrochlorothiazide 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dosage is doubled to 2 tablets of hydrochlorothiazide 12.5mg once daily for the following 3 weeks.
If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Spironolactone
Each patient will receive 1 tablet of spironolacton 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of spironolacton 12.5mg once daily for the following 3 weeks.
If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Lercanidipine
Each patients will receive 1 tablet of lercanidipine 10mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of lercanidipine 10mg once daily for the following 3 weeks.
If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Sodium intake intervention (B)
In this intervention group, the patients will receive two sodium diets in a randomized order. The following orders are possible:
1. High sodium intake- Low sodium intake
2. Low sodium intake- High sodium intake
High sodium dietary intake (>200mmol/l)
The patients will receive a 2-week high sodium diet. The patients will receive dietary advice to achieve this goal of \>200mmol/l sodium (\>12g salt) intake per day.
Low sodium dietary intake (<50mmol/l)
The patients will receive a 2-week low sodium diet. The patients will receive dietary advice to achieve this goal of \<50mmol/l sodium (\<3g salt) intake per day.
Water intake intervention (D)
In this intervention group, the patients will be prescribed two water interventions in a randomized order. The following orders are possible: 1. High water intake- Habitual water intake 2. Habitual water intake- High water intake
High water intake
During the increased water intake period, the patients will be instructed to drink 1 L more than their mean 24-hour urine volume at screening and baseline.
Habitual water intake
During this part of the intervention, the patients will be instructed to maintain their habitual water intake.
Interventions
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Hydrochlorothiazide
Each patient will receive 1 tablet of hydrochlorothiazide 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dosage is doubled to 2 tablets of hydrochlorothiazide 12.5mg once daily for the following 3 weeks.
If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Spironolactone
Each patient will receive 1 tablet of spironolacton 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of spironolacton 12.5mg once daily for the following 3 weeks.
If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Lercanidipine
Each patients will receive 1 tablet of lercanidipine 10mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of lercanidipine 10mg once daily for the following 3 weeks.
If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
High sodium dietary intake (>200mmol/l)
The patients will receive a 2-week high sodium diet. The patients will receive dietary advice to achieve this goal of \>200mmol/l sodium (\>12g salt) intake per day.
Low sodium dietary intake (<50mmol/l)
The patients will receive a 2-week low sodium diet. The patients will receive dietary advice to achieve this goal of \<50mmol/l sodium (\<3g salt) intake per day.
High water intake
During the increased water intake period, the patients will be instructed to drink 1 L more than their mean 24-hour urine volume at screening and baseline.
Habitual water intake
During this part of the intervention, the patients will be instructed to maintain their habitual water intake.
Eligibility Criteria
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Inclusion Criteria
2. Stable diuretic and antihypertensive treatment for the previous 6 weeks.
1. Chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2
2. Office blood pressure ≥140/90 mmHg or use of antihypertensive medication
3. Fasting morning urine osmolality \<425 mOsm/kg for men and \< 400 mOsm/kg for women
Exclusion Criteria
2. The patient is expected to start renal replacement therapy or is planned to receive a kidney transplantation within 3 months.
3. An active diagnosis of nephrotic syndrome at inclusion.
4. (Recurrent) acute glomerulonephritis within 1 year prior to the study.
5. Salt losing nephropathy.
6. Use of oral or intravenous glucocorticoids with an equivalent of prednisolone \>5mg/day.
7. Contra-indication for MRI.
8. Cardiovascular event/ surgery in the previous 3 months.
9. Pregnant women, women of child bearing age planning to conceive for the study duration, women of child bearing age without contraception.
10. Participation in other (pharmacological) intervention studies.
11. Presence of significant comorbidities with a life expectancy of less than 1 year.
12. Disorder that compromises the participants' ability to give truly informed consent for participation in this study.
13. Patients with an active infection and/or auto-immune diseases with involvement of the lower extremities.
14. Any other issues that in opinion of the investigator could be harmful to the subject or compromise interpretation of the data.
1\. Chronic use of NSAID
1. Serum potassium concentration \>5.0 mmol/l.
2. eGFR \<30 ml/min/1.73m2
3. Uncontrolled hypertension (\>180/100 mmHg)
4. Severe heart failure with left ventricular ejection fraction \<30%.
5. Contra-indication for investigational drugs.
6. Severe symptoms of (orthostatic) hypotension.
7. Patients with obstruction of the outflow tract of the left ventricle such as aortic valve stenosis.
8. Refractory hypokalemia, hyponatremia or hypercalcemia.
9. Severe liver insufficiency Child Pugh B/C
10. Chronic use of NSAID.
1. Recent history of severe hyponatremia (outpatient plasma sodium \< 130 mmol/L in the last 6 months)
2. Plasma sodium \<135 mmol/L at screening
3. History of heart failure
4. Use of lithium, vasopressin analoga, vasopressin antagonists, oral or intravenous glucocorticoids, thiazide diuretics.
5. 24-hour urine volume \> 2L
6. Chronic use of NSAID
18 Years
ALL
No
Sponsors
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Dutch Kidney Foundation
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Rik Olde Engberink
Internist-nephrologist, clinical pharmacologist
Principal Investigators
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Rik Olde Engberink, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location AMC
Locations
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Amsterdam UMC
Amsterdam-Zuidoost, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL82810.018.22
Identifier Type: -
Identifier Source: org_study_id
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