NCT07020104

The Role of Skin Sodium Accumulation in Chronic Kidney Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.
DIETARY_SUPPLEMENT	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	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	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.
DIETARY_SUPPLEMENT	Habitual water intake	During this part of the intervention, the patients will be instructed to maintain their habitual water intake.

Timeline

• Start date: 2025-01-07
• Primary completion: 2039-12-01
• Completion: 2039-12-01
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: Netherlands