Clinical trial NCT06970028: Somatosensory Phenotyping of ADPKD
Official title: Somatosensory Phenotyping of Patients With ADPKD Using Quantitative Sensory Testing and Questionnaires
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ADPKD
Pain
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ADPKD from the University Hospitals Leuven will be included in this study. Additionally, healthy volunteers will be included using the registered database of the Center for Clinical Pharmacology (UZ Leuven).

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 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 three questionnaires regarding pain and quality of life. These results will be compared with the somatosensory profile of matched healthy volunteers.


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.

Primary outcomes:
measure: Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST)
timeFrame: Interval of ≤ 3 months between screening and study visit
measure: Describing pain in ADPKD using the ADPKD-PDS questionnaire
timeFrame: Interval of ≤ 3 months between screening and study visit
measure: Describing neuropathic pain in ADPKD using the DN4 questionnaire
timeFrame: Interval of ≤ 3 months between screening and study visit
measure: Describing quality of life in ADPKD using the ADPKD-IS questionnaire
timeFrame: Interval of ≤ 3 months between screening and study visit
Secondary outcomes:
measure: Correlation between QST and questionnaires
timeFrame: Interval of ≤ 3 months between screening and study visit
measure: Differences in somatosensory phenotype depending on the disease stage of ADPKD
timeFrame: Interval of ≤ 3 months between screening and study visit
measure: Differences in somatosensory phenotype depending on the sex of patients with ADPKD
timeFrame: Interval of ≤ 3 months between screening and study visit
measure: Differences in pain and quality of life depending on the sex of patients with ADPKD
timeFrame: Interval of ≤ 3 months between screening and study visit.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Jan de Hoon, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: