An observational study in Chronic Kidney Disease-associated Pruritus, sponsored by Vifor (International) Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by Vifor (International) Inc. (part of CSL Limited) · Observational
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.
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).
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
Browse Pruritus studies →Vifor (International) Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted after Vifor (International) Inc. became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Day 1
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
Time frame: Day 1
Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape
in the management of CKD-aP
Time frame: Day 1
Impact of pruritus severity (WI-NRS)on HRQoL,
as reported by patients
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.
Pruritus and anti-itch
Time frame: Day 1
Clinical and healthcare resource outcomes in the last 12 months.
Missed or additional dialysis sessions, Hospitalizations, etc.
Time frame: Day 1
No study locations are listed for this record.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.
Access criteria: A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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