Chronic Kidney Disease-associated PruritusCKDNCT05625542
Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
An observational study of Chronic Kidney Disease-associated Pruritus, run by Vifor (International) Inc..
Trial summary
Vifor International Ltd. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease-associated Pruritus
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2023to 30 Jun 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
- Adult, Older adult
Study population: The study will consist of a random selection of approximately 3,330 male or female adult patients (≥18 years) undergoing HD within two large dialysis organization (DO) networks.
Who may be able to join
- Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent
- Signed informed consent
- Able and willing to fill in questionnaires
Who cannot join
- Patients receiving HD at home or both home and site
About this study
Official title: RELIEF CENSUS-US: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
Vifor International Ltd. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.
Read the detailed description
CKD-aP is a global clinical problem, and finding effective treatment remains a therapeutic challenge because of its complex pathophysiology (Sommer 2007, Weisshaar 2019, Yosipovitch 2013). The association between CKD-aP and clinical features and laboratory data remains unclear (Davison 2021, Manenti 2021). CKD-aP is thought to be associated with several conditions, including vitamin D deficiency, metabolic abnormalities (e.g., abnormal serum calcium or phosphate levels), toxin build-up, peripheral neuropathy, immune system dysregulation, or opioid receptor dysregulation (Jung 2015, Xie 2021, Kremer 2019, Verduzco 2020, Swarna 2019, Manenti 2021).
At present, there is no systematic assessment of CKD-aP in routine clinical practice, and the prevalence of CKD-aP is generally under-reported by patients and therefore underestimated by as much as 69% of healthcare professionals (HCPs) (Rayner 2017). Alleviating the burden of CKD-aP requires proactive identification of patients who suffer from it (Sukul 2020, Davison 2015, Phan 2012).
- Keywords
- CKD, CKD-AP, CKD associated pruritus
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours).
Ratio between the overall number of patients with WI-NRS scores ranging from 1-10 and the overall number of patients with WI-NRS scores ranging from 0-10, from patients randomly selected to participate in the study.
Measured: Day 1
Secondary outcomes (5)
Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours).
none (0), mild (1-3), moderate (4-6), or severe (7-10) scores
Measured: Day 1
Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape
in the management of CKD-aP
Measured: Day 1
Impact of pruritus severity (WI-NRS)on HRQoL,
as reported by patients
Measured: Day 1
Patient-reported communication with physician and other healthcare provider with respect to pruritus, as well as self-reported anti-itch treatments.
Pruritus and anti-itch
Measured: Day 1
Clinical and healthcare resource outcomes in the last 12 months.
Missed or additional dialysis sessions, Hospitalizations, etc.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start10 Jun 2023
- Primary completion10 Jun 2023
- Study completion30 Jun 2023 (estimated)
Why it stopped: The study will not be conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-associated PruritusStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor (International) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Despina Rüssmann, Dr, Study chair, CSL Vifor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625542
- Sponsor's protocol ID
- CS-DFK-2022-0027
- Acronym
- CKD
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF CENSUS-US: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05625542
- Acronym / sponsor ID
- CKD / CS-DFK-2022-0027
- Keywords
- CKD, CKD-AP, CKD associated pruritus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study will not be conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vifor (International) Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 23 Nov 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.
Vifor International Ltd. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.
Detailed description
CKD-aP is a global clinical problem, and finding effective treatment remains a therapeutic challenge because of its complex pathophysiology (Sommer 2007, Weisshaar 2019, Yosipovitch 2013). The association between CKD-aP and clinical features and laboratory data remains unclear (Davison 2021, Manenti 2021). CKD-aP is thought to be associated with several conditions, including vitamin D deficiency, metabolic abnormalities (e.g., abnormal serum calcium or phosphate levels), toxin build-up, peripheral neuropathy, immune system dysregulation, or opioid receptor dysregulation (Jung 2015, Xie 2021, Kremer 2019, Verduzco 2020, Swarna 2019, Manenti 2021).
At present, there is no systematic assessment of CKD-aP in routine clinical practice, and the prevalence of CKD-aP is generally under-reported by patients and therefore underestimated by as much as 69% of healthcare professionals (HCPs) (Rayner 2017). Alleviating the burden of CKD-aP requires proactive identification of patients who suffer from it (Sukul 2020, Davison 2015, Phan 2012).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will consist of a random selection of approximately 3,330 male or female adult patients (≥18 years) undergoing HD within two large dialysis organization (DO) networks.
Key inclusion criteria (3 listed)
- Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent
- Signed informed consent
- Able and willing to fill in questionnaires
Key exclusion criteria (1 listed)
- Patients receiving HD at home or both home and site
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
Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours).
Time frame: Day 1
Ratio between the overall number of patients with WI-NRS scores ranging from 1-10 and the overall number of patients with WI-NRS scores ranging from 0-10, from patients randomly selected to participate in the study.
5 secondary outcomes
Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours).
Time frame: Day 1
Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape
Time frame: Day 1
Impact of pruritus severity (WI-NRS)on HRQoL,
Time frame: Day 1
Patient-reported communication with physician and other healthcare provider with respect to pruritus, as well as self-reported anti-itch treatments.
Time frame: Day 1
Clinical and healthcare resource outcomes in the last 12 months.
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Related trials for Chronic Kidney Disease-associated Pruritus
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Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
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Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
Adverse Event, Peritoneal Dialysis
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Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial
Chronic Kidney Disease Associated Pruritus, End Stage Renal Disease on Dialysis
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Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in Treating Pruritus in Patients Undergoing Maintenance Hemodialysis
Chronic Kidney Disease-Associated Pruritus in Hemodialysis
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Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
Itching Symptoms, CKD 5D, Hemodialysis
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.
Despina Rüssmann, Dr study chair
CSL Vifor
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease-associated Pruritus, run by Vifor (International) Inc..
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 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: withdrawn, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 patients undergoing HD based on the WI-NRS score (past 24 hours). (time frame: Day 1). 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 5 Jul 2023.