Mapping sensory pain patterns in ADPKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses Quantitative Sensory Testing (QST) on the dominant hand and the lower back together with four questionnaires about pain and quality of life to map somatosensory profiles. Results from patients with ADPKD (age ≥12) will be compared with healthy volunteers matched for age, sex, and BMI. Key exclusions include current dialysis, prior kidney transplant, use of tolvaptan, skin problems at test sites, pregnancy or breastfeeding, and heavy alcohol or cannabis use. The aim is to better define pain mechanisms in ADPKD so future pain management and therapeutic approaches can be more targeted.

Why it matters

Who can join: the full rules

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.

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Jan de Hoon, MD, PhD, MSc — UZ Leuven
• Study coordinator: Flore Van Olmen, MSc
• Email: flore.vanolmen@uzleuven.be
• Phone: +32 016 34 22 01

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.