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Hexarelin

Examorelin, HEX

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Studies 233
Trials 61
Recruiting NA INTERVENTIONAL NCT07020104

The Role of Skin Sodium Accumulation in Chronic Kidney Disease

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Hydrochlorothiazide
Type: DRUG
Description: 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.
Name: Spironolactone
Type: DRUG
Description: 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.
Name: Lercanidipine
Type: DRUG
Description: 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.
Name: High sodium dietary intake (>200mmol/l)
Type: DIETARY_SUPPLEMENT
Description: 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.
Name: Low sodium dietary intake (<50mmol/l)
Type: DIETARY_SUPPLEMENT
Description: 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.
Name: High water intake
Type: DIETARY_SUPPLEMENT
Description: 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.
Name: Habitual water intake
Type: DIETARY_SUPPLEMENT
Description: During this part of the intervention, the patients will be instructed to maintain their habitual water intake.

Primary Outcomes

Measure: Skin sodium content at baseline (A)
TimeFrame: 0 week
Description: Skin sodium content will be measured using the 7T sodium MRI
Measure: Muscle sodium content at baseline (A)
TimeFrame: 0 week
Description: Muscle sodium content will be measured using the 7T sodium MRI
Measure: Change from baseline in tissue sodium content after low and high sodium diet (B)
TimeFrame: 2 weeks
Description:
Measure: Change in tissue sodium content after treatment with hydrochloorthiazide, spironolacton and lercanidipine (C)
TimeFrame: 6 weeks
Description: 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.
Measure: Change from baseline in tissue sodium content after habitual and high water intake (D)
TimeFrame: 4 weeks
Description: To evaluate the effect of high and habitual water intake on tissue sodium content.
Measure: Change from baseline in transepidermal water loss after habitual and high water intake (D)
TimeFrame: 4 weeks
Description: To evaluate the effect of high and habitual water intake on transepidermal water loss.
Measure: Incidence of hyponatremia and hypervolemia (D)
TimeFrame: 4 weeks
Description: Safety of high water intake in CKD patients with eGFR between 15 and 30ml/min/1.73m2

Trial Information

NCT ID

NCT07020104

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Last Updated

December 15, 2025