Chronic Kidney DiseasesUP-RAISENCT05415969
CKD-aP Among Adults on Dialysis in Switzerland
An observational study of Chronic Kidney Diseases and Dialysis, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
Trial summary
Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a localized or a generalized skin itch, which is a common symptom occurring in end-stage renal disease and dialysis. The prevalence of CKD-aP in adults on dialysis varies between countries ranging between 20-42%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Dialysis, Chronic Kidney Diseases Associated Pruritus
- What is being tested?
- CKD-aP
- How many people
- 401 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 9 Oct 2023
- 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: Adult patients on hemodialysis or peritoneal dialysis followed by nephrologists in private and public hospitals of the French speaking Part of Switzerland.
Who may be able to join
- Adult ≥ 18 years old
- Diagnosed with end-stage renal disease and receiving hemodialysis for at least 6 months
- Able to communicate in French or availability of a French-speaking close relative for translation
- Signed informed consent
- Additional inclusion criteria for the case-control study outcomes phase 2:
- Reporting moderate to severe CKD-aP for the participant considered as a case
- Reporting no or mild CKD-aP for the participant considered as a control Cases and controls will be matched by age-group, sex, and dialysis modality (hemodialysis or peritoneal dialysis).
Who cannot join
- Presence of cognitive impairment or cognitive disorder
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011
About this study
Official title: Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland
Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a localized or a generalized skin itch, which is a common symptom occurring in end-stage renal disease and dialysis. The prevalence of CKD-aP in adults on dialysis varies between countries ranging between 20-42%. Swiss data on CKD-aP are unfortunately largely lacking, as Switzerland is so far not part of large registries, such as DOPPS.
The aging population, the increase in diabetes (69% by 2030), the increase in hypertension (60% by 2025) and poly-morbidity will probably lead to a rise in the number of patients on dialysis and subsequent CKD-aP.
Read more
CKD-aP is associated with sleep disturbances, compromised quality of life, emotional distress, and increased risks of hospitalization and death. Its management lacks approaches that are supported by strong evidence because its pathogenesis remains poorly understood and may be related to an increase in uremic toxins, skin inflammation. In this context, sweat composition deserves more attention.
Aim of the study The aim of the study is to determine the prevalence of CKD-aP in the population on dialysis, the association between CKD-aP and different electrolytes, and the potential role of the composition of sweat in CKD-aP.
Results will be used for building a CKD-aP symptom management program to improve the quality of care of patients on dialysis and will be incorporated in the nursing continuing education program.
- Being tested
- CKD-aP
- Keywords
- Chronic Kidney Disease; Dialysis; Pruritus
- Medical subject headings
- Renal Insufficiency, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-aPOther
Identification of CKD-aP prevalence and severity among patients on dialysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CKD-aP
Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.
Measured: June 27, 2022- October 31, 2023
Severity of CKD-aP using the Visual Analog Scale
Severity of CKD-aP will be measured using the Visual Analog Scale (VAS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours.
The VAS score ranges from 0 (not itchy) to 10 (extremely itchy); Severity will be classified into five categories: 1) 0 = no pruritus, 2) 0.1-2.9 points = mild pruritus, 3) 3.0-6.9 points = moderate pruritus, 4) 7.0-8.9 points = severe pruritus, and 5) 9.0-10.0 points = very severe pruritus. Higher scores indicate a worse outcome.
Measured: June 27, 2022- October 31, 2023
Severity of CKD-aP using the Verbal Rating Scale
Severity of CKD-aP will also be measured using the Verbal Rating Scale (VRS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours.
The VRS is a five-point scale and consists of a list of adjectives describing various levels of symptom intensity (0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch and 4=very severe itch). Higher scores indicate a worse outcome.
Measured: June 27, 2022- October 31, 2023
Secondary outcomes (6)
Sodium level (mmol/l) in sweat
Measurement of sodium (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.
60 participants (30 cases and 30 controls)
Measured: June 27, 2022- October 31, 2023
Chloride level (mmol/l) in sweat
Measurement of chloride (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.
60 participants (30 cases and 30 controls)
Measured: June 27, 2022- October 31, 2023
Potassium level (mmol/l) in sweat
Measurement of potassium (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.
60 participants (30 cases and 30 controls)
Measured: June 27, 2022- October 31, 2023
Calcium level (mg/l) in sweat
Measurement of calcium (mg/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.
60 participants (30 cases and 30 controls)
Measured: June 27, 2022- October 31, 2023
Phosphorus level (mg/ml) in sweat
Measurement of phosphorus (mg/ml) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.
60 participants (30 cases and 30 controls)
Measured: June 27, 2022- October 31, 2023
Urea level (mmol/l) in sweat
Measurement of urea (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.
60 participants (30 cases and 30 controls)
Measured: June 27, 2022- October 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Sep 2022
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Cross-sectional
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences of Western Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, Hôpital Fribourgeois, University Hospital, Geneva, Valais Hospital, eHnv Hospital, Rennaz Hospital, Intercantonal Hospital of Broye, GHOL Nyon Hospital, Dialyse Riviera, Cecil Clinic Hirslanden Private Hospital Group, Vifor Pharma, Réseau Hospitalier Neuchâtelois
- Responsible party
- Principal investigator, Nancy Helou, University of Applied Sciences of Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415969
- Sponsor's protocol ID
- 2022-00670
- Acronym
- UP-RAISE
- Status last verified
- Nov 2023
- First submitted
- 1 Jun 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized Data can be shared upon justified request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland
- ClinicalTrials.gov ID
- NCT05415969
- Acronym / sponsor ID
- UP-RAISE / 2022-00670
- Keywords
- Chronic Kidney Disease; Dialysis; Pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University of Applied Sciences of Western SwitzerlandUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, Hôpital Fribourgeois, University Hospital, Geneva, Valais Hospital, eHnv Hospital, Rennaz Hospital, Intercantonal Hospital of Broye, GHOL Nyon Hospital, Dialyse Riviera, Cecil Clinic Hirslanden Private Hospital Group, Vifor Pharma, Réseau Hospitalier Neuchâtelois
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 13 Jun 2022 (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 Associated Pruritus (CKD-aP) represents a localized or a generalized skin itch, which is a common symptom occurring in end-stage renal disease and dialysis. The prevalence of CKD-aP in adults on dialysis varies between countries ranging between 20-42%. Swiss data on CKD-aP are unfortunately largely lacking, as Switzerland is so far not part of large registries, such as DOPPS.
The aging population, the increase in diabetes (69% by 2030), the increase in hypertension (60% by 2025) and poly-morbidity will probably lead to a rise in the number of patients on dialysis and subsequent CKD-aP.
CKD-aP is associated with sleep disturbances, compromised quality of life, emotional distress, and increased risks of hospitalization and death. Its management lacks approaches that are supported by strong evidence because its pathogenesis remains poorly understood and may be related to an increase in uremic toxins, skin inflammation. In this context, sweat composition deserves more attention.
Aim of the study The aim of the study is to determine the prevalence of CKD-aP in the population on dialysis, the association between CKD-aP and different electrolytes, and the potential role of the composition of sweat in CKD-aP.
Results will be used for building a CKD-aP symptom management program to improve the quality of care of patients on dialysis and will be incorporated in the nursing continuing education program.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients on hemodialysis or peritoneal dialysis followed by nephrologists in private and public hospitals of the French speaking Part of Switzerland.
Key inclusion criteria (7 listed)
- Adult ≥ 18 years old
- Diagnosed with end-stage renal disease and receiving hemodialysis for at least 6 months
- Able to communicate in French or availability of a French-speaking close relative for translation
- Signed informed consent
- Reporting moderate to severe CKD-aP for the participant considered as a case
Key exclusion criteria (1 listed)
- Presence of cognitive impairment or cognitive disorder
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 |
|---|---|---|
| CKD-aPIdentification of CKD-aP prevalence and severity among patients on dialysis. | Other | – |
Primary outcome
Prevalence of CKD-aP
Time frame: June 27, 2022- October 31, 2023
Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.
Severity of CKD-aP using the Visual Analog Scale
Time frame: June 27, 2022- October 31, 2023
Severity of CKD-aP will be measured using the Visual Analog Scale (VAS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours. The VAS score ranges from 0 (not itchy) to 10 (extremely itchy); Severity will be classified into five categories: 1) 0 = no pruritus, 2) 0.1-2.9 points = mild pruritus, 3) 3.0-6.9 points = moderate pruritus, 4) 7.0-8.9 points = severe pruritus, and 5) 9.0-10.0 points = very severe pruritus. Higher scores indicate a worse outcome.
Severity of CKD-aP using the Verbal Rating Scale
Time frame: June 27, 2022- October 31, 2023
Severity of CKD-aP will also be measured using the Verbal Rating Scale (VRS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours. The VRS is a five-point scale and consists of a list of adjectives describing various levels of symptom intensity (0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch and 4=very severe itch). Higher scores indicate a worse outcome.
6 secondary outcomes
Sodium level (mmol/l) in sweat
Time frame: June 27, 2022- October 31, 2023
Chloride level (mmol/l) in sweat
Time frame: June 27, 2022- October 31, 2023
Potassium level (mmol/l) in sweat
Time frame: June 27, 2022- October 31, 2023
Calcium level (mg/l) in sweat
Time frame: June 27, 2022- October 31, 2023
Phosphorus level (mg/ml) in sweat
Time frame: June 27, 2022- October 31, 2023
Urea level (mmol/l) in sweat
Time frame: June 27, 2022- October 31, 2023
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 18 Nov 2023.
- Individual participant dataSharing planned: Undecided. Anonymized Data can be shared upon justified request.
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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 Diseases and Dialysis, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
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 7 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 18 Nov 2023. 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 Switzerland. 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?
Prevalence of CKD-aP (time frame: June 27, 2022- October 31, 2023). The study lists 3 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 18 Nov 2023.