DIALYSIS SYMPTOMS AND ANXIETYNCT07465042
Symptom Clusters in Hemodialysis : Insights From a Multicenter Analysis Using Tetrachoric Correlations
An observational study of DIALYSIS SYMPTOMS AND ANXIETY and Hemodialysis, run by Calydial at 6 sites in France.
Trial summary
In 2025, Guerraoui et al. published the Concordance Study in Clinical Kidney Journal, a large multicenter cross-sectional study embedded within the French REIN registry. This study compared symptoms reported by hemodialysis patients using the Dialysis Symptom Index (DSI) with clinician-perceived symptoms, revealing a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DIALYSIS SYMPTOMS AND ANXIETY, Hemodialysis
- What is being tested?
- observational cross sectional study
- How many people
- 256 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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: Hemodialysis patients in six dialysis centres and self-dialysis units in the Rhône-Alpes region of France
Who may be able to join
- undergoing maintenance hemodialysis
- ≥18 years
- dialysis vintage ≥3 months
Who cannot join
- patients with cognitive impairment (which was assessed with the presence of either clinical judgement or formal diagnosis)
- patients who did not have the ability to express consent or refused to participant in the study
- patients who could not read or understand French well enough to complete the questionnaire.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Saint Joseph Saint Luc
Lyon, 69000
HCL Edouard Herriot
Lyon, 69000
HCL Lyon Sud
Lyon, 69000
ARTIC42
Saint-Etienne, 42055
CHAL
Sallanches, 74700
CALYDIAL
Vienne, 38200
About this study
In 2025, Guerraoui et al. published the Concordance Study in Clinical Kidney Journal, a large multicenter cross-sectional study embedded within the French REIN registry. This study compared symptoms reported by hemodialysis patients using the Dialysis Symptom Index (DSI) with clinician-perceived symptoms, revealing a high symptom burden and marked patient-clinician discordance [3].
The present work is a secondary analysis of the Concordance Study dataset. Building on the original findings, this analysis aims to deepen understanding of symptom organization and determinants in hemodialysis using multivariate and correlation-based approaches. Specifically, our objectives were :
Read more
- to identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering;
- to examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression.
Through this secondary analysis, we aim to clarify the internal architecture of symptom co-occurrence, identify key demographic drivers such as sex, and generate evidence supporting cluster-informed, individualized approaches to symptom assessment and management in routine nephrology care.
- Conditions
- DIALYSIS SYMPTOMS AND ANXIETY, Hemodialysis
- Being tested
- observational cross sectional study
- Keywords
- hemodialysis, dialysis, symptoms, clinician-perceived symptoms, PROM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational cross sectional studyOther
no intervention : observational
What is being measured
The primary outcome is the main question the study is designed to answer.
identify and characterize symptom clusters
identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering
Measured: one day enrollment
examine associations between symptoms (and clusters) and comorbidity burden
examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression
Measured: one day enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIALYSIS SYMPTOMS AND ANXIETYStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calydial
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465042
- Sponsor's protocol ID
- Symptom Clusters in HD
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Clusters in Hemodialysis : Insights From a Multicenter Analysis Using Tetrachoric Correlations
- ClinicalTrials.gov ID
- NCT07465042
- Acronym / sponsor ID
- Symptom Clusters in HD
- Conditions
- DIALYSIS SYMPTOMS AND ANXIETY, Hemodialysis
- Keywords
- hemodialysis, dialysis, symptoms, clinician-perceived symptoms, PROM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- CalydialUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Mar 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.
In 2025, Guerraoui et al. published the Concordance Study in Clinical Kidney Journal, a large multicenter cross-sectional study embedded within the French REIN registry. This study compared symptoms reported by hemodialysis patients using the Dialysis Symptom Index (DSI) with clinician-perceived symptoms, revealing a high symptom burden and marked patient-clinician discordance [3].
The present work is a secondary analysis of the Concordance Study dataset. Building on the original findings, this analysis aims to deepen understanding of symptom organization and determinants in hemodialysis using multivariate and correlation-based approaches. Specifically, our objectives were :
- to identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering;
- to examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression.
Through this secondary analysis, we aim to clarify the internal architecture of symptom co-occurrence, identify key demographic drivers such as sex, and generate evidence supporting cluster-informed, individualized approaches to symptom assessment and management in routine nephrology care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients in six dialysis centres and self-dialysis units in the Rhône-Alpes region of France
Key inclusion criteria (3 listed)
- undergoing maintenance hemodialysis
- ≥18 years
- dialysis vintage ≥3 months
Key exclusion criteria (3 listed)
- patients with cognitive impairment (which was assessed with the presence of either clinical judgement or formal diagnosis)
- patients who did not have the ability to express consent or refused to participant in the study
- patients who could not read or understand French well enough to complete the questionnaire.
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 |
|---|---|---|
| observational cross sectional studyno intervention : observational | Other | – |
Primary outcome
identify and characterize symptom clusters
Time frame: one day enrollment
identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering
examine associations between symptoms (and clusters) and comorbidity burden
Time frame: one day enrollment
examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression
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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. all IPD collected
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DIALYSIS SYMPTOMS AND ANXIETY and Hemodialysis, run by Calydial at 6 sites in France.
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 3 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
identify and characterize symptom clusters (time frame: one day enrollment). 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?
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 11 Mar 2026.