Chronic Kidney DiseaseNCT06363097
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease and Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- How many people
- 130 participants
- Where
- 1 siteGreece
- Study dates
- 4 Sep 2023to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: This study includes patients with CKD across all consecutive pre-dialysis stages.
Who may be able to join
- Age ≥18 years
- CKD defined based on the KDIGO criteria
- Provision of informed written consent
Who cannot join
- Kidney transplantation or end-stage kidney disease (ESKD) under hemodialysis or peritoneal dialysis
- Chronic atrial fibrillation or other diagnosed arrhythmia intervening with a proper 24-hour ABPM recording
- Inability to reliably complete the study questionnaires
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Greece1 site
1st Department of Nephrology
Thessaloniki, Central Macedonia, 54642
About this study
Official title: The Effect of Dietary Sodium Intake on Ambulatory Blood Pressure Levels According to Urinary Uromodulin Levels in Patients With Chronic Kidney Disease
In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients.
Read the detailed description
This is a cross-sectional study performed in the 1st Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. For the purposes of this study, adult (aged ≥18 years) CKD patients (defined based on the KDIGO criteria) fulfilling the inclusion and exclusion criteria were invited to participate. All included patients signed a written informed consent form prior to study enrollment. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki and the and the Institutional Review Board of Hippokration Hospital, Thessaloniki, Greece. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment and directives of the General Data Protection Regulation (GDPR).
Baseline evaluation includes the recording of demographics, anthropometric characteristics, CKD cause, comorbidities, concomitant medications, as well as a detailed physical examination and venous blood sampling for routine laboratory tests. Study participants are advised to refrain from food, caffeine, alcohol, or tobacco for 12 h and receive any standard medication before their morning appointment in the research laboratory to perform the assessments described below. Office BP measurements are performed thrice after 5-10 min of rest, in the sitting position, at the level of the brachial artery, with a validated oscillometric device [Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan)] using a cuff of appropriate size, according to current guidelines. Afterwards, evaluation of patient's hydration status will be performed with lung ultrasound [GE VScan (GE Healthcare, Horten, Norway)] through quantification of US-B lines. The Mini-Mental State Exam (MMSE) is used for the assessment of cognitive function; sleep quality is evaluated by the Pittsburg Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS), while the severity of nocturia is also recorded. Following that, patients will undergo a 24-hour ambulatory BP monitoring (ABPM) with ABPMpro (SOMNOmedics, Randersacker, Germany) with an appropriately sized cuff. The device will take measurements every 20 minutes between 07:00 and 23:00 (daytime period) and every 30 minutes between 23:00 and 07:00 (nighttime period). Simultaneously, patients will perform a 24-hour urine collection, divided in two distinct periods (daytime and nighttime) with the use of two different containers matching the corresponding ABPM periods.
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- CKD, Uromodulin, sodium intake
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low uromodulin group | Patients with urinary uromodulin levels below median. | |
| High uromodulin group | Patients with urinary uromodulin levels above median. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure.
In patients with high and low urinary uromodulin excretion, investigation of the relationship of 24-hour urinary sodium excretion with 24-hour ambulatory systolic blood pressure.
Measured: Baseline
Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory diastolic blood pressure.
In patients with high and low urinary uromodulin excretion, investigation of the relationship of 24-hour urinary sodium excretion with 24-hour ambulatory diastolic blood pressure.
Measured: Baseline
Secondary outcomes (36)
Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure.
In patients with high and low urinary uromodulin excretion, investigation of the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure.
Measured: Baseline
Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure.
In patients with high and low urinary uromodulin excretion, investigation of the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure.
Measured: Baseline
Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure.
In patients with high and low urinary uromodulin excretion, investigation of the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure.
Measured: Baseline
Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure.
In patients with high and low urinary uromodulin excretion, investigation of the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure.
Measured: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP between patients with high and low urinary uromodulin excretion.
Measured: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP standard deviation (SD) between patients with high and low urinary uromodulin excretion.
Measured: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP weighted SD (wSD) between patients with high and low urinary uromodulin excretion.
Measured: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV) between patients with high and low urinary uromodulin excretion.
Measured: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP average real variability (ARV) between patients with high and low urinary uromodulin excretion.
Measured: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP standard deviation (SD).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP average real variability (ARV).
(This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the ABPMpro device).
Measured: Baseline
Effect of 24-hour urinary sodium excretion on hydration status (US-B lines).
(The hydration status will be assessed through quantification of US-B lines using GE VScan lung ultrasound device).
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on hydration status (US-B lines).
(The hydration status will be assessed through quantification of US-B lines using GE VScan lung ultrasound device).
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on hydration status (US-B lines).
(The hydration status will be assessed through quantification of US-B lines using GE VScan lung ultrasound device).
Measured: Baseline
Effect of 24-hour urinary sodium excretion on MMSE score.
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on MMSE score.
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on MMSE score.
Measured: Baseline
Effect of 24-hour urinary sodium excretion on PSQI score.
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on PSQI score.
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on PSQI score.
Measured: Baseline
Effect of 24-hour urinary sodium excretion on ESS score.
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on ESS score.
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on ESS score.
Measured: Baseline
Effect of 24-hour urinary sodium excretion on nocturnal urinations.
Measured: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on nocturnal urinations.
Measured: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on nocturnal urinations.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start4 Sep 2023
- Primary completion30 Apr 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363097
- Sponsor's protocol ID
- ΔΔ5032
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karagiannidis AG, Theodorakopoulou MP, Pella E, Sarafidis PA, Ortiz A. Uromodulin biology. Nephrol Dial Transplant. 2024 Jun 28;39(7):1073-1087. doi: 10.1093/ndt/gfae008.
PubMed 38211973Padmanabhan S, Melander O, Johnson T, Di Blasio AM, Lee WK, Gentilini D, Hastie CE, Menni C, Monti MC, Delles C, Laing S, Corso B, Navis G, Kwakernaak AJ, van der Harst P, Bochud M, Maillard M, Burnier M, Hedner T, Kjeldsen S, Wahlstrand B, Sjogren M, Fava C, Montagnana M, Danese E, Torffvit O, Hedblad B, Snieder H, Connell JM, Brown M, Samani NJ, Farrall M, Cesana G, Mancia G, Signorini S, Grassi G, Eyheramendy S, Wichmann HE, Laan M, Strachan DP, Sever P, Shields DC, Stanton A, Vollenweider P, Teumer A, Volzke H, Rettig R, Newton-Cheh C, Arora P, Zhang F, Soranzo N, Spector TD, Lucas G, Kathiresan S, Siscovick DS, Luan J, Loos RJ, Wareham NJ, Penninx BW, Nolte IM, McBride M, Miller WH, Nicklin SA, Baker AH, Graham D, McDonald RA, Pell JP, Sattar N, Welsh P; Global BPgen Consortium; Munroe P, Caulfield MJ, Zanchetti A, Dominiczak AF. Genome-wide association study of blood pressure extremes identifies variant near UMOD associated with hypertension. PLoS Genet. 2010 Oct 28;6(10):e1001177. doi: 10.1371/journal.pgen.1001177.
PubMed 21082022Trudu M, Janas S, Lanzani C, Debaix H, Schaeffer C, Ikehata M, Citterio L, Demaretz S, Trevisani F, Ristagno G, Glaudemans B, Laghmani K, Dell'Antonio G; SKIPOGH team; Loffing J, Rastaldi MP, Manunta P, Devuyst O, Rampoldi L. Common noncoding UMOD gene variants induce salt-sensitive hypertension and kidney damage by increasing uromodulin expression. Nat Med. 2013 Dec;19(12):1655-60. doi: 10.1038/nm.3384. Epub 2013 Nov 3.
PubMed 24185693Ponte B, Sadler MC, Olinger E, Vollenweider P, Bochud M, Padmanabhan S, Hayward C, Kutalik Z, Devuyst O. Mendelian randomization to assess causality between uromodulin, blood pressure and chronic kidney disease. Kidney Int. 2021 Dec;100(6):1282-1291. doi: 10.1016/j.kint.2021.08.032. Epub 2021 Oct 9.
PubMed 34634361Ponte B, Pruijm M, Ackermann D, Olinger E, Youhanna S, Vogt B, Burnier M, Pechere-Bertschi A, Bochud M, Devuyst O. Uromodulin, Salt, and 24-Hour Blood Pressure in the General Population. Clin J Am Soc Nephrol. 2021 May 8;16(5):787-789. doi: 10.2215/CJN.11230720. Epub 2021 Jan 21. No abstract available.
PubMed 33478975Torffvit O, Melander O, Hulten UL. Urinary excretion rate of Tamm-Horsfall protein is related to salt intake in humans. Nephron Physiol. 2004;97(1):p31-6. doi: 10.1159/000077600.
PubMed 15153749Bakhoum CY, Anderson CAM, Juraschek SP, Rebholz CM, Appel LJ, Miller ER, Parikh CR, Obeid W, Rifkin DE, Ix JH, Garimella PS. The Relationship Between Urine Uromodulin and Blood Pressure Changes: The DASH-Sodium Trial. Am J Hypertens. 2021 Mar 11;34(2):154-156. doi: 10.1093/ajh/hpaa140.
PubMed 32856709Bakhoum CY, Matheson MB, Greenberg JH, Furth SL, Ix JH, Garimella PS. Urine Uromodulin Is Not Associated With Blood Pressure in the Chronic Kidney Disease in Children Cohort. Hypertension. 2022 Oct;79(10):2298-2304. doi: 10.1161/HYPERTENSIONAHA.122.19566. Epub 2022 Aug 3.
PubMed 35920156McCallum L, Brooksbank K, McConnachie A, Aman A, Lip S, Dawson J, MacIntyre IM, MacDonald TM, Webb DJ, Padmanabhan S. Rationale and Design of the Genotype-Blinded Trial of Torasemide for the Treatment of Hypertension (BHF UMOD). Am J Hypertens. 2021 Feb 18;34(1):92-99. doi: 10.1093/ajh/hpaa166.
PubMed 33084880Karagiannidis AG, Baroutidou A, Theodorakopoulou M, Karkamani E, Manti S, Afkou Z, Vagdatli E, Faitatzidou D, Giamalis P, Papadopoulos C, Sarafidis P. Effects of urine uromodulin levels on the association between sodium intake and ambulatory blood pressure in individuals with chronic kidney disease. Eur J Intern Med. 2026 Apr 25:106903. doi: 10.1016/j.ejim.2026.106903. Online ahead of print.
PubMed 42036287
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Sodium Intake on Ambulatory Blood Pressure Levels According to Urinary Uromodulin Levels in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06363097
- Acronym / sponsor ID
- ΔΔ5032
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- CKD, Uromodulin, sodium intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 12 Apr 2024 (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.
In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients.
Detailed description
This is a cross-sectional study performed in the 1st Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. For the purposes of this study, adult (aged ≥18 years) CKD patients (defined based on the KDIGO criteria) fulfilling the inclusion and exclusion criteria were invited to participate. All included patients signed a written informed consent form prior to study enrollment. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki and the and the Institutional Review Board of Hippokration Hospital, Thessaloniki, Greece. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment and directives of the General Data Protection Regulation (GDPR).
Baseline evaluation includes the recording of demographics, anthropometric characteristics, CKD cause, comorbidities, concomitant medications, as well as a detailed physical examination and venous blood sampling for routine laboratory tests. Study participants are advised to refrain from food, caffeine, alcohol, or tobacco for 12 h and receive any standard medication before their morning appointment in the research laboratory to perform the assessments described below. Office BP measurements are performed thrice after 5-10 min of rest, in the sitting position, at the level of the brachial artery, with a validated oscillometric device [Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan)] using a cuff of appropriate size, according to current guidelines. Afterwards, evaluation of patient's hydration status will be performed with lung ultrasound [GE VScan (GE Healthcare, Horten, Norway)] through quantification of US-B lines. The Mini-Mental State Exam (MMSE) is used for the assessment of cognitive function; sleep quality is evaluated by the Pittsburg Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS), while the severity of nocturia is also recorded. Following that, patients will undergo a 24-hour ambulatory BP monitoring (ABPM) with ABPMpro (SOMNOmedics, Randersacker, Germany) with an appropriately sized cuff. The device will take measurements every 20 minutes between 07:00 and 23:00 (daytime period) and every 30 minutes between 23:00 and 07:00 (nighttime period). Simultaneously, patients will perform a 24-hour urine collection, divided in two distinct periods (daytime and nighttime) with the use of two different containers matching the corresponding ABPM periods.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low uromodulin group | – | –Patients with urinary uromodulin levels below median. |
| High uromodulin group | – | –Patients with urinary uromodulin levels above median. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes patients with CKD across all consecutive pre-dialysis stages.
Key inclusion criteria (3 listed)
- Age ≥18 years
- CKD defined based on the KDIGO criteria
- Provision of informed written consent
Key exclusion criteria (4 listed)
- Kidney transplantation or end-stage kidney disease (ESKD) under hemodialysis or peritoneal dialysis
- Chronic atrial fibrillation or other diagnosed arrhythmia intervening with a proper 24-hour ABPM recording
- Inability to reliably complete the study questionnaires
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure.
Time frame: Baseline
In patients with high and low urinary uromodulin excretion, investigation of the relationship of 24-hour urinary sodium excretion with 24-hour ambulatory systolic blood pressure.
Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory diastolic blood pressure.
Time frame: Baseline
In patients with high and low urinary uromodulin excretion, investigation of the relationship of 24-hour urinary sodium excretion with 24-hour ambulatory diastolic blood pressure.
36 secondary outcomes
Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure.
Time frame: Baseline
Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure.
Time frame: Baseline
Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure.
Time frame: Baseline
Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure.
Time frame: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP between patients with high and low urinary uromodulin excretion.
Time frame: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP standard deviation (SD) between patients with high and low urinary uromodulin excretion.
Time frame: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP weighted SD (wSD) between patients with high and low urinary uromodulin excretion.
Time frame: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV) between patients with high and low urinary uromodulin excretion.
Time frame: Baseline
The difference in 24-hour ambulatory brachial SBP/DBP average real variability (ARV) between patients with high and low urinary uromodulin excretion.
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD).
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD).
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV).
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV).
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD).
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD).
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV).
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV).
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP standard deviation (SD).
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD).
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV).
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP average real variability (ARV).
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on hydration status (US-B lines).
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on hydration status (US-B lines).
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on hydration status (US-B lines).
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on MMSE score.
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on MMSE score.
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on MMSE score.
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on PSQI score.
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on PSQI score.
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on PSQI score.
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on ESS score.
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on ESS score.
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on ESS score.
Time frame: Baseline
Effect of 24-hour urinary sodium excretion on nocturnal urinations.
Time frame: Baseline
Effect of nighttime/daytime ratio of urinary sodium excretion on nocturnal urinations.
Time frame: Baseline
Effect of urinary sodium-to-potassium (Na+/K+) ratio on nocturnal urinations.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 38211973Karagiannidis AG, Theodorakopoulou MP, Pella E, Sarafidis PA, Ortiz A. Uromodulin biology. Nephrol Dial Transplant. 2024 Jun 28;39(7):1073-1087. doi: 10.1093/ndt/gfae008.
- Background: PubMed 21082022Padmanabhan S, Melander O, Johnson T, Di Blasio AM, Lee WK, Gentilini D, Hastie CE, Menni C, Monti MC, Delles C, Laing S, Corso B, Navis G, Kwakernaak AJ, van der Harst P, Bochud M, Maillard M, Burnier M, Hedner T, Kjeldsen S, Wahlstrand B, Sjogren M, Fava C, Montagnana M, Danese E, Torffvit O, Hedblad B, Snieder H, Connell JM, Brown M, Samani NJ, Farrall M, Cesana G, Mancia G, Signorini S, Grassi G, Eyheramendy S, Wichmann HE, Laan M, Strachan DP, Sever P, Shields DC, Stanton A, Vollenweider P, Teumer A, Volzke H, Rettig R, Newton-Cheh C, Arora P, Zhang F, Soranzo N, Spector TD, Lucas G, Kathiresan S, Siscovick DS, Luan J, Loos RJ, Wareham NJ, Penninx BW, Nolte IM, McBride M, Miller WH, Nicklin SA, Baker AH, Graham D, McDonald RA, Pell JP, Sattar N, Welsh P; Global BPgen Consortium; Munroe P, Caulfield MJ, Zanchetti A, Dominiczak AF. Genome-wide association study of blood pressure extremes identifies variant near UMOD associated with hypertension. PLoS Genet. 2010 Oct 28;6(10):e1001177. doi: 10.1371/journal.pgen.1001177.
- Background: PubMed 24185693Trudu M, Janas S, Lanzani C, Debaix H, Schaeffer C, Ikehata M, Citterio L, Demaretz S, Trevisani F, Ristagno G, Glaudemans B, Laghmani K, Dell'Antonio G; SKIPOGH team; Loffing J, Rastaldi MP, Manunta P, Devuyst O, Rampoldi L. Common noncoding UMOD gene variants induce salt-sensitive hypertension and kidney damage by increasing uromodulin expression. Nat Med. 2013 Dec;19(12):1655-60. doi: 10.1038/nm.3384. Epub 2013 Nov 3.
- Background: PubMed 34634361Ponte B, Sadler MC, Olinger E, Vollenweider P, Bochud M, Padmanabhan S, Hayward C, Kutalik Z, Devuyst O. Mendelian randomization to assess causality between uromodulin, blood pressure and chronic kidney disease. Kidney Int. 2021 Dec;100(6):1282-1291. doi: 10.1016/j.kint.2021.08.032. Epub 2021 Oct 9.
- Background: PubMed 33478975Ponte B, Pruijm M, Ackermann D, Olinger E, Youhanna S, Vogt B, Burnier M, Pechere-Bertschi A, Bochud M, Devuyst O. Uromodulin, Salt, and 24-Hour Blood Pressure in the General Population. Clin J Am Soc Nephrol. 2021 May 8;16(5):787-789. doi: 10.2215/CJN.11230720. Epub 2021 Jan 21. No abstract available.
- Background: PubMed 15153749Torffvit O, Melander O, Hulten UL. Urinary excretion rate of Tamm-Horsfall protein is related to salt intake in humans. Nephron Physiol. 2004;97(1):p31-6. doi: 10.1159/000077600.
- Background: PubMed 32856709Bakhoum CY, Anderson CAM, Juraschek SP, Rebholz CM, Appel LJ, Miller ER, Parikh CR, Obeid W, Rifkin DE, Ix JH, Garimella PS. The Relationship Between Urine Uromodulin and Blood Pressure Changes: The DASH-Sodium Trial. Am J Hypertens. 2021 Mar 11;34(2):154-156. doi: 10.1093/ajh/hpaa140.
- Background: PubMed 35920156Bakhoum CY, Matheson MB, Greenberg JH, Furth SL, Ix JH, Garimella PS. Urine Uromodulin Is Not Associated With Blood Pressure in the Chronic Kidney Disease in Children Cohort. Hypertension. 2022 Oct;79(10):2298-2304. doi: 10.1161/HYPERTENSIONAHA.122.19566. Epub 2022 Aug 3.
- Background: PubMed 33084880McCallum L, Brooksbank K, McConnachie A, Aman A, Lip S, Dawson J, MacIntyre IM, MacDonald TM, Webb DJ, Padmanabhan S. Rationale and Design of the Genotype-Blinded Trial of Torasemide for the Treatment of Hypertension (BHF UMOD). Am J Hypertens. 2021 Feb 18;34(1):92-99. doi: 10.1093/ajh/hpaa166.
- Derived from this study: PubMed 42036287Karagiannidis AG, Baroutidou A, Theodorakopoulou M, Karkamani E, Manti S, Afkou Z, Vagdatli E, Faitatzidou D, Giamalis P, Papadopoulos C, Sarafidis P. Effects of urine uromodulin levels on the association between sodium intake and ambulatory blood pressure in individuals with chronic kidney disease. Eur J Intern Med. 2026 Apr 25:106903. doi: 10.1016/j.ejim.2026.106903. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jan 2026. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06363097, which also lists 10 linked publications.
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 27 Jan 2026.