Actively Recruiting
The Role of Skin Sodium Accumulation in Chronic Kidney Disease
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-06-13
60
Participants Needed
1
Research Sites
777 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
D
Dutch Kidney Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Role of Skin Sodium Accumulation in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2
- Stable diuretic and antihypertensive treatment for the previous 6 weeks
- For sodium excretion intervention: office systolic blood pressure greater than 135 mmHg
- For water intervention: chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2
- For water intervention: office blood pressure 140/90 mmHg or higher or use of antihypertensive medication
- For water intervention: fasting morning urine osmolality less than 425 mOsm/kg for men and less than 400 mOsm/kg for women
You will not qualify if you...
- Age under 18 years
- Expected to start renal replacement therapy or planned kidney transplantation within 3 months
- Active nephrotic syndrome at inclusion
- Recurrent acute glomerulonephritis within 1 year prior to the study
- Salt losing nephropathy
- Use of oral or intravenous glucocorticoids equivalent to prednisolone more than 5 mg/day
- Contraindication for MRI
- Cardiovascular event or surgery in the previous 3 months
- Pregnant women, women planning conception during study, or women without contraception
- Participation in other pharmacological intervention studies
- Significant comorbidities with life expectancy less than 1 year
- Conditions preventing informed consent
- Active infection or autoimmune diseases involving the lower extremities
- Other issues deemed harmful by investigator
- For sodium intake intervention: chronic use of NSAIDs
- For sodium excretion intervention: serum potassium above 5.0 mmol/l, eGFR below 30 ml/min/1.73m2, uncontrolled hypertension above 180/100 mmHg, severe heart failure with ejection fraction below 30%, contraindication for study drugs, severe orthostatic hypotension, obstruction of left ventricular outflow, refractory low potassium or sodium or high calcium, severe liver insufficiency Child Pugh B/C, chronic NSAID use
- For water intake intervention: recent severe hyponatremia, plasma sodium below 135 mmol/l at screening, history of heart failure, use of lithium or vasopressin drugs or glucocorticoids or thiazide diuretics, 24-hour urine volume above 2 liters, chronic NSAID use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam-Zuidoost, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
R
Rik Olde Engberink, MD, PhD
CONTACT
S
Sanédy Simon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here