Somatosensory Phenotyping of ADPKD

Официальное название

Somatosensory Phenotyping of Patients With ADPKD Using Quantitative Sensory Testing and Questionnaires

Обзор

Over 60% of patients with ADPKD suffer from pain, mostly in the abdomen, flank and back, often leading to the diagnosis. It is challenging to manage and cure the pain; approximately 39% of patients are not satisfied with their pain treatment, since the pain prevents them from doing various activities, affecting their quality of life. Pain can be present before enlargement of the kidneys, the source of the pain is often unknown and common analgesics are insufficient to manage the pain or cannot be taken due to renal impairment. By further investigating and characterizing the pain phenotype of the ADPKD population, pain management might be improved and alternative therapeutic approaches might be developed. In this clinical study, pain will be assessed in patients with ADPKD using Quantitative Sensory Testing (QST) on the dominant hand and the lower back, together with four questionnaires regarding pain and quality of life. These results will be compared with the somatosensory profile of matched healthy volunteers.

Вмешательства

• Другое Quantitative Sensory Testing
  We will perform QST on the dominant hand and lower back.
• Другое Questionnaires regarding pain and quality of life
  Questionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life.

Первичные конечные точки

• Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST) [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Describing pain in ADPKD using the ADPKD-PDS questionnaire [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Describing neuropathic pain in ADPKD using the DN4 questionnaire [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Describing quality of life in ADPKD using the ADPKD-IS questionnaire [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Comparing pain between patients with ADPKD and healthy volunteers using the BPI-SF questionnaire [Срок оценки: Interval of ≤ 3 months between screening and study visit]

Вторичные конечные точки (4)

• Correlation between QST and questionnaires [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Differences in somatosensory phenotype depending on the disease stage of ADPKD [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Differences in somatosensory phenotype depending on the sex of patients with ADPKD [Срок оценки: Interval of ≤ 3 months between screening and study visit]
• Differences in pain and quality of life depending on the sex of patients with ADPKD [Срок оценки: Interval of ≤ 3 months between screening and study visit]

Критерии участия

Критерии включения

Patients with ADPKD

• Subject is ≥ 12 years old.
• Subject is diagnosed with ADPKD.

Healthy volunteers

• Subject is ≥ 12 years old.
• Subject is in good general health, based on medical history and vital signs.
• Subject is matched to the patient group for age, sex and BMI.

Критерии исключения

Patients with ADPKD

• Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand and/or lower back which, in the investigator's opinion, might interfere with the study assessments.
• Subject is currently undergoing dialysis, had a kidney transplant or is a user of tolvaptan.
• Female who is pregnant or breastfeeding.
• Simultaneous participation in another study which, in the investigator's opinion, might confound the results of the study.
• Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, and/or consumes ≥ 3 alcoholic consumptions per day.
• Subject is a regular user of cannabis, any illicit drugs and/or has a history of drug abuse.
• Subject is unable to refrain from drinking caffeinated beverages (such as coffee, tea, cola,…) 24 hours prior to each study visit.
• Subject has used concomitant drugs and/or treatments in a period smaller than or equal to 5 half-lives prior to enrollment, that may interfere, in the investigator's opinion, with the study results.
• Subject has a history of any illness or condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study.

Healthy volunteers

• Subject has a history of any illness or condition which may affect the normal somatosensory functionality.
• Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand and/or lower back which, in the investigator's opinion, might interfere with the study assessments.
• Female who is pregnant or breast-feeding.
• Simultaneous participation in another study which, in the investigator's opinion, might confound the results of the study.
• Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, and/or consumes ≥ 3 alcoholic consumptions per day.
• Subject is a regular user of cannabis, any illicit drugs and/or has a history of drug abuse.
• Subject is unable to refrain from drinking caffeinated beverages (such as coffee, tea, cola,…) 24 hours prior to each study visit.
• Subject has used concomitant drugs and/or treatments in a period smaller than or equal to 5 half-lives prior to enrollment, that may interfere, in the investigator's opinion, with the study results.
• Subject has a history of any illness or condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Бельгия · 1 центр

• UZ Leuven — Leuven

Идентификаторы

NCT: NCT06970028 · S70540

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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