Status:
RECRUITING
Somatosensory Phenotyping of ADPKD
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
ADPKD
Pain
Eligibility:
All Genders
12+ years
Brief Summary
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06970028
Start Date
September 9 2025
End Date
December 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000