Somatosensory Phenotyping of ADPKD

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial, titled “Somatosensory Phenotyping of ADPKD,” is studying the pain experienced by patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Over 60% of these patients suffer from pain, mostly in areas like the abdomen and back, which can significantly affect their daily activities and quality of life. The trial aims to better understand the nature of this pain by using special tests and questionnaires to assess how it impacts patients compared to healthy volunteers. The goal is to improve pain management and develop better treatment options for those affected.

Eligible participants include individuals aged 12 and older with a confirmed diagnosis of ADPKD. Healthy volunteers who are also 12 years or older and in good general health can participate if they are matched to the patient group by age, sex, and body mass index (BMI). Participants can expect to undergo pain assessments on their dominant hand and lower back, along with completing questionnaires about their pain and overall quality of life. It's important to note that some individuals may not qualify due to specific health conditions or medications that could interfere with the study results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.