Chronic Kidney Disease (CKD)SQUIL-CKDNCT07808944
Trace Element Imbalances in Dialysis Patients With CKD: the Role of Hemodialysis
An observational study of Chronic Kidney Disease (CKD), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Chronic kidney disease (CKD) is associated with alterations in the balance of trace elements and metals, which may result from reduced dietary intake, impaired renal function, dialysis-related removal, or environmental exposure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Compare blood concentrations of selected trace elements and metals before and after hemodialysis
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to 31 Mar 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage IV and Vd chronic kidney disease (CKD)-both those about to start dialysis (incident patients) and those who have been on dialysis for at least 5 years (prevalent patients)
Who may be able to join
- Patients aged 60 years or older;
- Patients attending the Nephrology and Dialysis Unit (SCDU) of AOU AL;
- Patients about to start hemodialysis (HD) using the bicarbonate dialysis (BIC-HD) technique (Group A patients) or patients already on dialysis for at least 5 years using the bicarbonate dialysis (BIC-HD) technique (Group B patients);
- Patients with stage V or Vd chronic kidney disease (CKD);
- Signature of informed consent.
Who cannot join
- Patients with previous kidney transplants (resumption of dialysis treatment after the transplant period).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trace Element Imbalances in Patients With Chronic Kidney Disease (CKD) Undergoing Dialysis: the Role of Hemodialysis Treatment as an Environmental Factor
Chronic kidney disease (CKD) is associated with alterations in the balance of trace elements and metals, which may result from reduced dietary intake, impaired renal function, dialysis-related removal, or environmental exposure. Hemodialysis may play a relevant role in both the removal and potential introduction of these elements. This pilot study aims to investigate trace element and metal imbalances in older patients with advanced CKD and to assess the influence of bicarbonate hemodialysis and dialysis-related environmental exposure on their elemental profile.
Read the detailed description
This is a prospective, observational, monocentric pilot study involving patients aged 60 years or older with advanced chronic kidney disease (CKD).
Participants will be divided into two groups: patients about to start bicarbonate hemodialysis (BIC-HD) and patients undergoing BIC-HD for at least 5 years, with at least 10 patients per group.
The study aims to assess blood levels of selected trace elements and metals, including zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium, before and after hemodialysis, and to investigate the potential influence of dialysis treatment and dialysis-related environmental exposure.
Blood and dialysate samples will be collected before and after dialysis, together with samples of the tap water used for the treatment. Samples will be analyzed using inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectrometry (ICP-OES).
Clinical and laboratory data will also be collected to investigate the association between elemental imbalances and selected clinical manifestations, including cardiovascular and infectious events, anemia, peripheral neuropathy, cognitive impairment and malnutrition. Cognitive function will be assessed at baseline and after 6 months using the FACT-Cog questionnaire.
Participants will be followed for 6 months. The study has an overall duration of 12 months, including enrollment, follow-up, sample analysis and statistical evaluation.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Compare blood concentrations of selected trace elements and metals before and after hemodialysis
- 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.
Compare blood concentrations of selected trace elements and metals before and after hemodialysisOther
The main objective is to compare blood concentrations of selected trace elements and metals before and after hemodialysis in incident and prevalent patients. The elements investigated will include zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium. The study will also investigate whether the elemental profile differs according to the duration of exposure to hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Incident patients | Patients with stage V/Vd CKD who are about to start bicarbonate hemodialysis (BIC-HD). 10 patients will be enrolled in this group. Receives: Other: Compare blood concentrations of selected trace elements and metals before and after hemodialysis | |
| Prevalent patients | Patients who have been receiving BIC-HD for at least 5 years. 10 patients will be enrolled in this group. Receives: Other: Compare blood concentrations of selected trace elements and metals before and after hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of circulating trace element levels
Comparison of blood levels of trace elements regarding deficiency and excess in the incident and prevalent patients groups, before and after dialysis treatment
Measured: Baseline, pre and post treatment and after 6 months
Secondary outcomes (4)
Evaluation of the impact of hemodialysis treatment
Evaluation of the impact of hemodialysis treatment on the removal of metals in blood and the dialysis bath
Measured: Baseline and after 6 month
Association between baseline trace elements levels and clinical manifestations.
Statistical evaluation of any association between baseline trace elements levels and clinical manifestations.
Measured: Baseline and after 6 month
Predictor of mortality
Evaluation of Cu/Zn ratio as a predictor of mortality
Measured: Baseline and after 6 month
FACT-Cog questionnaire.
Assessment of cognitive function through FACT-Cog questionnaire, a 5-point Likert scale (ranging from 0 to 4 per item).
Measured: Baseline and after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start31 Mar 2025
- Primary completion28 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808944
- Sponsor's protocol ID
- ASO.Nefro.24.03
- Acronym
- SQUIL-CKD
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trace Element Imbalances in Patients With Chronic Kidney Disease (CKD) Undergoing Dialysis: the Role of Hemodialysis Treatment as an Environmental Factor
- ClinicalTrials.gov ID
- NCT07808944
- Acronym / sponsor ID
- SQUIL-CKD / ASO.Nefro.24.03
- Conditions
- Chronic Kidney Disease (CKD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 9 Sep 2026 (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.
Chronic kidney disease (CKD) is associated with alterations in the balance of trace elements and metals, which may result from reduced dietary intake, impaired renal function, dialysis-related removal, or environmental exposure. Hemodialysis may play a relevant role in both the removal and potential introduction of these elements. This pilot study aims to investigate trace element and metal imbalances in older patients with advanced CKD and to assess the influence of bicarbonate hemodialysis and dialysis-related environmental exposure on their elemental profile.
Detailed description
This is a prospective, observational, monocentric pilot study involving patients aged 60 years or older with advanced chronic kidney disease (CKD).
Participants will be divided into two groups: patients about to start bicarbonate hemodialysis (BIC-HD) and patients undergoing BIC-HD for at least 5 years, with at least 10 patients per group.
The study aims to assess blood levels of selected trace elements and metals, including zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium, before and after hemodialysis, and to investigate the potential influence of dialysis treatment and dialysis-related environmental exposure.
Blood and dialysate samples will be collected before and after dialysis, together with samples of the tap water used for the treatment. Samples will be analyzed using inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectrometry (ICP-OES).
Clinical and laboratory data will also be collected to investigate the association between elemental imbalances and selected clinical manifestations, including cardiovascular and infectious events, anemia, peripheral neuropathy, cognitive impairment and malnutrition. Cognitive function will be assessed at baseline and after 6 months using the FACT-Cog questionnaire.
Participants will be followed for 6 months. The study has an overall duration of 12 months, including enrollment, follow-up, sample analysis and statistical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incident patients | – | Other: Compare blood concentrations of selected trace elements and metals before and after hemodialysisPatients with stage V/Vd CKD who are about to start bicarbonate hemodialysis (BIC-HD). 10 patients will be enrolled in this group. |
| Prevalent patients | – | Other: Compare blood concentrations of selected trace elements and metals before and after hemodialysisPatients who have been receiving BIC-HD for at least 5 years. 10 patients will be enrolled in this group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage IV and Vd chronic kidney disease (CKD)-both those about to start dialysis (incident patients) and those who have been on dialysis for at least 5 years (prevalent patients)
Key inclusion criteria (5 listed)
- Patients aged 60 years or older;
- Patients attending the Nephrology and Dialysis Unit (SCDU) of AOU AL;
- Patients about to start hemodialysis (HD) using the bicarbonate dialysis (BIC-HD) technique (Group A patients) or patients already on dialysis for at least 5 years using the bicarbonate dialysis (BIC-HD) technique (Group B patients);
- Patients with stage V or Vd chronic kidney disease (CKD);
- Signature of informed consent.
Key exclusion criteria (1 listed)
- Patients with previous kidney transplants (resumption of dialysis treatment after the transplant period).
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 |
|---|---|---|
| Compare blood concentrations of selected trace elements and metals before and after hemodialysisThe main objective is to compare blood concentrations of selected trace elements and metals before and after hemodialysis in incident and prevalent patients. The elements investigated will include zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium. The study will also investigate whether the elemental profile differs according to the duration of exposure to hemodialysis. | Other | Incident patients, Prevalent patients |
Primary outcome
Profile of circulating trace element levels
Time frame: Baseline, pre and post treatment and after 6 months
Comparison of blood levels of trace elements regarding deficiency and excess in the incident and prevalent patients groups, before and after dialysis treatment
4 secondary outcomes
Evaluation of the impact of hemodialysis treatment
Time frame: Baseline and after 6 month
Association between baseline trace elements levels and clinical manifestations.
Time frame: Baseline and after 6 month
Predictor of mortality
Time frame: Baseline and after 6 month
FACT-Cog questionnaire.
Time frame: Baseline and after 6 month
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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 (CKD), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 5 inclusion and 1 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 9 Sep 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 Italy. 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?
Profile of circulating trace element levels (time frame: Baseline, pre and post treatment and after 6 months). 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 9 Sep 2026.