Chronic Kidney DiseasesSKIN-CKDNCT07020104
The Role of Skin Sodium Accumulation in Chronic Kidney Disease
A study testing Hydrochlorothiazide, Spironolactone and Lercanidipine in people with Chronic Kidney Diseases, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This project consists of four substudies: a cohort study (A) and a sodium intake intervention (B) and a sodium excretion intervention (C) and a water intervention study (D). The main objective of the cohort study (A) is to investigate the prognostic implications of tissue sodium accumulation in CKD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Hydrochlorothiazide, Spironolactone and Lercanidipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jan 2025to 1 Dec 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2.
- Stable diuretic and antihypertensive treatment for the previous 6 weeks.
- Additional inclusion criteria for the sodium excretion intervention 1. Office systolic blood pressure (SBP) >135 mmHg
- Additional inclusion criteria for the water intervention
- Chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2
- Office blood pressure ≥140/90 mmHg or use of antihypertensive medication
- Fasting morning urine osmolality <425 mOsm/kg for men and < 400 mOsm/kg for women
Who cannot join
- Age <18 years.
- The patient is expected to start renal replacement therapy or is planned to receive a kidney transplantation within 3 months.
- An active diagnosis of nephrotic syndrome at inclusion.
- (Recurrent) acute glomerulonephritis within 1 year prior to the study.
- Salt losing nephropathy.
- Use of oral or intravenous glucocorticoids with an equivalent of prednisolone >5mg/day.
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- Contra-indication for MRI.
- Cardiovascular event/ surgery in the previous 3 months.
- Pregnant women, women of child bearing age planning to conceive for the study duration, women of child bearing age without contraception.
- Participation in other (pharmacological) intervention studies.
- Presence of significant comorbidities with a life expectancy of less than 1 year.
- Disorder that compromises the participants' ability to give truly informed consent for participation in this study.
- Patients with an active infection and/or auto-immune diseases with involvement of the lower extremities.
- Any other issues that in opinion of the investigator could be harmful to the subject or compromise interpretation of the data.
- Additional exclusion criteria for the sodium intake intervention
- 1. Chronic use of NSAID
- Additional exclusion criteria for the sodium excretion intervention
- Serum potassium concentration >5.0 mmol/l.
- eGFR <30 ml/min/1.73m2
- Uncontrolled hypertension (>180/100 mmHg)
- Severe heart failure with left ventricular ejection fraction <30%.
- Contra-indication for investigational drugs.
- Severe symptoms of (orthostatic) hypotension.
- Patients with obstruction of the outflow tract of the left ventricle such as aortic valve stenosis.
- Refractory hypokalemia, hyponatremia or hypercalcemia.
- Severe liver insufficiency Child Pugh B/C
- Chronic use of NSAID.
- Additional exclusion criteria for the water intake intervention
- Recent history of severe hyponatremia (outpatient plasma sodium < 130 mmol/L in the last 6 months)
- Plasma sodium <135 mmol/L at screening
- History of heart failure
- Use of lithium, vasopressin analoga, vasopressin antagonists, oral or intravenous glucocorticoids, thiazide diuretics.
- 24-hour urine volume > 2L
- Chronic use of NSAID
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam-Zuidoost, North Holland, 1105AZ
Rik Olde Engberink, MD,PhD, +31 0205669111 ext. 27445, r.h.oldeengberink@amsterdamumc.nl
Sanédy Simon, MD, +31 0205661930, s.s.a.simon@amsterdamumc.nl
About this study
This project consists of four substudies: a cohort study (A) and a sodium intake intervention (B) and a sodium excretion intervention (C) and a water intervention study (D).
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.
Read the detailed description
Cohort study (A):
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
- Chronic Kidney Diseases
- Being tested
- Hydrochlorothiazide, Spironolactone, Lercanidipine, High sodium dietary intake (>200mmol/l), Low sodium dietary intake (<50mmol/l)
- Keywords
- Skin sodium, Sodium MRI, CKD, Prognosis, Cardiovascular event, Renal event, Quality of life, Tissue sodium
- 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.
HydrochlorothiazideDrug
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.
SpironolactoneDrug
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.
LercanidipineDrug
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)Dietary supplement
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)Dietary supplement
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 intakeDietary supplement
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 intakeDietary supplement
During this part of the intervention, the patients will be instructed to maintain their habitual water intake.
| Study group | Role | What they receive |
|---|---|---|
| Sodium excretion intervention (C) | Experimental | 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 Receives: Drug: Hydrochlorothiazide; Drug: Spironolactone; Drug: Lercanidipine |
| Sodium intake intervention (B) | Experimental | 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 Receives: Dietary Supplement: High sodium dietary intake (>200mmol/l); Dietary Supplement: Low sodium dietary intake (<50mmol/l) |
| Water intake intervention (D) | Experimental | 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 Receives: Dietary Supplement: High water intake; Dietary Supplement: Habitual water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin sodium content at baseline (A)
Skin sodium content will be measured using the 7T sodium MRI
Measured: 0 week
Muscle sodium content at baseline (A)
Muscle sodium content will be measured using the 7T sodium MRI
Measured: 0 week
Change from baseline in tissue sodium content after low and high sodium diet (B)
Measured: 2 weeks
Change in tissue sodium content after treatment with hydrochloorthiazide, spironolacton and lercanidipine (C)
To study the effect of hydrochloorthiazide, spironolacton and lercanidipine on tissue sodium content, to compare the effect among the various antihypertensive agents and to assess the effect of blood pressure regulation, increased renal sodium excretion and aldosteron blockade on tissue sodium content.
Measured: 6 weeks
Change from baseline in tissue sodium content after habitual and high water intake (D)
To evaluate the effect of high and habitual water intake on tissue sodium content.
Measured: 4 weeks
Change from baseline in transepidermal water loss after habitual and high water intake (D)
To evaluate the effect of high and habitual water intake on transepidermal water loss.
Measured: 4 weeks
Incidence of hyponatremia and hypervolemia (D)
Safety of high water intake in CKD patients with eGFR between 15 and 30ml/min/1.73m2
Measured: 4 weeks
Secondary outcomes (27)
Correlation between tissue sodium content and total vessel density (A)
Correlation between tissue sodium content measured with 7T Na-MRI and total vessel density using Sidestream Dark Field imaging.
Measured: 0 week
Correlation between tissue sodium content and perfused vessel density (A)
Correlation between tissue sodium content measured with 7T Na-MRI and perfused vessel density using Sidestream Dark Field imaging.
Measured: 0 week
Correlation between tissue sodium content and proportion of perfused vessels (A)
Correlation between tissue sodium content measured with 7T Na-MRI and proportion of perfused vessels using Sidestream Dark Field imaging.
Measured: 0 week
Correlation between tissue sodium content and microvascular flow index (A)
Correlation between tissue sodium content measured with 7T Na-MRI and microvascular flow index using Sidestream Dark Field imaging.
Measured: 0 week
Correlation between tissue sodium content and microvascular health score (A)
Correlation between tissue sodium content measured with 7T Na-MRI and microvascular health score using Sidestream Dark Field imaging.
Measured: 0 week
Correlation between tissue sodium content and total pheripheral resistance (A)
Total pheripheral resistance will be measured using the Nexfin device and tissue sodium content will be measured using the 7T Na-MRI
Measured: 0 week
Correlation between tissue sodium content and cardiac output (A)
Cardiac output will be measured using the Nexfin device and tissue sodium content will be measured using the 7T Na MRI
Measured: 0 week
Correlation between tissue sodium content and transepidermal water loss (A)
Transepidermal water loss will be measured with the Tewameter® TM Hex probe and tissue sodium content will be measured using the 7T Na MRI
Measured: 0 week
Correlation between tissue sodium content and office systolic and diastolic blood pressure (A)
Tissue sodium content will be measured using the 7T sodium MRI
Measured: 0 week
Correlation between tissue sodium content and 24-hour systolic and diastolic blood pressure (A)
Tissue sodium content will be measured using the 7T Na MRI
Measured: 0 week
Correlation between tissue sodium content and nightime blood pressure dipping pattern (A)
The nighttime blood pressure dipping pattern will be measured with a 24-hour blood pressure measurements. Patients will be classified as a 'dippers' when the nighttime systolic blood pressure and/or diastolic blood pressure falls >10% and <20% compared to daytime readings. Exteme dippers are described as those with blood pressure fall of at least 20%. Patients with blood pressure fall between 0 and 10% are classified as non-dippers.
Measured: 0 week
Correlation between tissue sodium content and total body water (A)
Total body water (liter) will be measured using the bioelectrical impendance analysis and tissue sodium content will be measured using the 7T Na MRI
Measured: 0 week
Correlation between tissue sodium content and quality of life (A)
Quality of life(QoL) will be measured with the Kidney Disease Quality of Life questionnaire at baseline and yearly during follow-up and tissue sodium comntent will be measured using the 7T Na MRI at baseline
Measured: At baseline and yearly during follow-up
The correlation between tissue sodium content and traditional cardiovascular risk factors (A)
In the cohort study, the correlation between tissue sodium content measured with 7T Na MRI and the known traditional cardiovascular risk factors will be studied.
Measured: 15 years
Change from baseline in plasma co-peptine concentrations (D)
For waterintake intervention study
Measured: 4 weeks
Change from baseline in seated systolic and diastolic office blood pressure (B/C/D)
Seated office systolic and diastolic blood pressure after interventions compared to baseline
Measured: 2 weeks
Change from baseline in 24-hour systolic and diastolic blood pressure (B/C/D)
24-hour systolic and diastolic blood pressure after interventions compared to baseline
Measured: 2 weeks
Change from baseline in percentage of patients with a night-time blood pressure dipping pattern (B/C/D)
Nighttime blood pressure dipping status will be measured with a 24-hour blood pressure measurements. Patients will be classified as a 'dippers' when the nighttime systolic blood pressure and/or diastolic blood pressure falls >10% and <20% compared to daytime readings. Exteme dippers are described as those with blood pressure fall of at least 20%. Patients with blood pressure fall between 0 and 10% are classified as non-dippers.
Measured: 2 weeks
Change from baseline in transepidermal water loss (B/C/D)
Transepidermal water loss will be measured with the Tewameter® TM Hex probe
Measured: 2 weeks
Change from baseline in total body water (B/C/D)
Total body water will be measured using the bioelectrical impendance analysis
Measured: 2 weeks
Change from baseline in total vessel density (B/C/D)
The total vessel density will be measured using Sidestream Dark Field imaging.
Measured: 2 weeks
Change from baseline in perfused vessel density (B/C/D)
The perfused vessel density will be measured using Sidestream Dark Field imaging.
Measured: 2 weeks
Change from baseline in proportion of perfused vessel (B/C/D)
The proportion of perfused vessels will be measured using Sidestream Dark Field imaging.
Measured: 2 weeks
Change from baseline in microvascular flow index (B/C/D)
The microvascular flow index will be measured using Sidestream Dark Field imaging.
Measured: 2 weeks
Change from baseline in microvascular health score (B/C/D)
The microvascular health score will be measured using Sidestream Dark Field imaging.
Measured: 2 weeks
Change from baseline in total peripheral resistance (B/C/D)
The total pheripheral resistance will be measured using the Nexfin device
Measured: 2 weeks
Change from baseline in cardiac output (B/C/D)
The cardiac output will be measured using the Nexfin device
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start7 Jan 2025
- Primary completion1 Dec 2039 (estimated)
- Study completion1 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The association between tissue sodium accumulation and cardiovascular parameters, body composition, skin hydration and transepidermal water loss, renal and cardiovascular outcome will be studied in 60 CKD patients (A). 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Responsible party
- Principal investigator, Rik Olde Engberink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Rik Olde Engberink, MD, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020104
- Sponsor's protocol ID
- NL82810.018.22
- Acronym
- SKIN-CKD
- Status last verified
- Jun 2025
- First submitted
- 15 Apr 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researcher
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Skin Sodium Accumulation in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07020104
- Acronym / sponsor ID
- SKIN-CKD / NL82810.018.22
- Conditions
- Chronic Kidney Diseases
- Keywords
- Skin sodium, Sodium MRI, CKD, Prognosis, Cardiovascular event, Renal event, Quality of life, Tissue sodium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Dec 2039 (estimated)
- Study completion
- 1 Dec 2039 (estimated)
- First posted
- 13 Jun 2025 (actual)
- 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.
This project consists of four substudies: a cohort study (A) and a sodium intake intervention (B) and a sodium excretion intervention (C) and a water intervention study (D).
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.
Detailed description
Cohort study (A):
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The association between tissue sodium accumulation and cardiovascular parameters, body composition, skin hydration and transepidermal water loss, renal and cardiovascular outcome will be studied in 60 CKD patients (A). 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.
| Arm | Type | Receives |
|---|---|---|
| Sodium excretion intervention (C) | Experimental | Drug: Hydrochlorothiazide, Drug: Spironolactone, Drug: LercanidipineIn 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 |
| Sodium intake intervention (B) | Experimental | Dietary Supplement: High sodium dietary intake (>200mmol/l), Dietary Supplement: Low sodium dietary intake (<50mmol/l)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 |
| Water intake intervention (D) | Experimental | Dietary Supplement: High water intake, Dietary Supplement: Habitual water intakeIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2.
- Stable diuretic and antihypertensive treatment for the previous 6 weeks.
- Additional inclusion criteria for the sodium excretion intervention 1. Office systolic blood pressure (SBP) >135 mmHg
- Additional inclusion criteria for the water intervention
- Chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2
Key exclusion criteria (34 listed)
- Age <18 years.
- The patient is expected to start renal replacement therapy or is planned to receive a kidney transplantation within 3 months.
- An active diagnosis of nephrotic syndrome at inclusion.
- (Recurrent) acute glomerulonephritis within 1 year prior to the study.
- Salt losing nephropathy.
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 |
|---|---|---|
| HydrochlorothiazideEach 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. | Drug | Sodium excretion intervention (C) |
| SpironolactoneEach 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. | Drug | Sodium excretion intervention (C) |
| LercanidipineEach 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. | Drug | Sodium excretion intervention (C) |
| 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. | Dietary supplement | Sodium intake intervention (B) |
| 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. | Dietary supplement | Sodium intake intervention (B) |
| High water intakeDuring 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. | Dietary supplement | Water intake intervention (D) |
| Habitual water intakeDuring this part of the intervention, the patients will be instructed to maintain their habitual water intake. | Dietary supplement | Water intake intervention (D) |
Primary outcome
Skin sodium content at baseline (A)
Time frame: 0 week
Skin sodium content will be measured using the 7T sodium MRI
Muscle sodium content at baseline (A)
Time frame: 0 week
Muscle sodium content will be measured using the 7T sodium MRI
Change from baseline in tissue sodium content after low and high sodium diet (B)
Time frame: 2 weeks
Change in tissue sodium content after treatment with hydrochloorthiazide, spironolacton and lercanidipine (C)
Time frame: 6 weeks
To study the effect of hydrochloorthiazide, spironolacton and lercanidipine on tissue sodium content, to compare the effect among the various antihypertensive agents and to assess the effect of blood pressure regulation, increased renal sodium excretion and aldosteron blockade on tissue sodium content.
Change from baseline in tissue sodium content after habitual and high water intake (D)
Time frame: 4 weeks
To evaluate the effect of high and habitual water intake on tissue sodium content.
Change from baseline in transepidermal water loss after habitual and high water intake (D)
Time frame: 4 weeks
To evaluate the effect of high and habitual water intake on transepidermal water loss.
Incidence of hyponatremia and hypervolemia (D)
Time frame: 4 weeks
Safety of high water intake in CKD patients with eGFR between 15 and 30ml/min/1.73m2
27 secondary outcomes
Correlation between tissue sodium content and total vessel density (A)
Time frame: 0 week
Correlation between tissue sodium content and perfused vessel density (A)
Time frame: 0 week
Correlation between tissue sodium content and proportion of perfused vessels (A)
Time frame: 0 week
Correlation between tissue sodium content and microvascular flow index (A)
Time frame: 0 week
Correlation between tissue sodium content and microvascular health score (A)
Time frame: 0 week
Correlation between tissue sodium content and total pheripheral resistance (A)
Time frame: 0 week
Correlation between tissue sodium content and cardiac output (A)
Time frame: 0 week
Correlation between tissue sodium content and transepidermal water loss (A)
Time frame: 0 week
Correlation between tissue sodium content and office systolic and diastolic blood pressure (A)
Time frame: 0 week
Correlation between tissue sodium content and 24-hour systolic and diastolic blood pressure (A)
Time frame: 0 week
Correlation between tissue sodium content and nightime blood pressure dipping pattern (A)
Time frame: 0 week
Correlation between tissue sodium content and total body water (A)
Time frame: 0 week
Correlation between tissue sodium content and quality of life (A)
Time frame: At baseline and yearly during follow-up
The correlation between tissue sodium content and traditional cardiovascular risk factors (A)
Time frame: 15 years
Change from baseline in plasma co-peptine concentrations (D)
Time frame: 4 weeks
Change from baseline in seated systolic and diastolic office blood pressure (B/C/D)
Time frame: 2 weeks
Change from baseline in 24-hour systolic and diastolic blood pressure (B/C/D)
Time frame: 2 weeks
Change from baseline in percentage of patients with a night-time blood pressure dipping pattern (B/C/D)
Time frame: 2 weeks
Change from baseline in transepidermal water loss (B/C/D)
Time frame: 2 weeks
Change from baseline in total body water (B/C/D)
Time frame: 2 weeks
Change from baseline in total vessel density (B/C/D)
Time frame: 2 weeks
Change from baseline in perfused vessel density (B/C/D)
Time frame: 2 weeks
Change from baseline in proportion of perfused vessel (B/C/D)
Time frame: 2 weeks
Change from baseline in microvascular flow index (B/C/D)
Time frame: 2 weeks
Change from baseline in microvascular health score (B/C/D)
Time frame: 2 weeks
Change from baseline in total peripheral resistance (B/C/D)
Time frame: 2 weeks
Change from baseline in cardiac output (B/C/D)
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researcher
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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.
Rik Olde Engberink, MD, PhD principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrochlorothiazide, Spironolactone and Lercanidipine in people with Chronic Kidney Diseases, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 7 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rik Olde Engberink, MD, PhD (+31 0205669111 ext. 27445, r.h.oldeengberink@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin sodium content at baseline (A) (time frame: 0 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.