Somatosensory Phenotyping of ADPKD

NCT06970028 | Recruiting

• 1 other identifier: S70540
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

ADPKD; Pain

Outcome Measures

Primary Outcomes (5)

• Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST)

  The somatosensory phenotype of patients with ADPKD will be evaluated using QST on the dominant hand and lower back. These results will be compared with the somatosensory phenotype of matched healthy volunteers.

  Interval of ≤ 3 months between screening and study visit

• Describing pain in ADPKD using the ADPKD-PDS questionnaire

  (Potential) pain in the last 7 days will be assessed using the ADPKD-PDS questionnaire, which contains 20 questions (1-5 Likert scale) in 7 domains: Dull Pain Severity, Sharp Pain Severity, Discomfort Severity, Overall Pain and Discomfort Severity, Dull Pain Interference, Sharp Pain Interference, and Discomfort Interference. Unit of Measure: Total score per domain

  Interval of ≤ 3 months between screening and study visit

• Describing neuropathic pain in ADPKD using the DN4 questionnaire

  The DN4 questionnaire will be used to evaluate whether the (potential) pain is neuropathic. The questionnaire consists of 10 yes/no questions, in which a total score of 4/10 or higher is considered indicative of neuropathic pain. Unit of Measure: Total DN4 score (/10)

  Interval of ≤ 3 months between screening and study visit

• Describing quality of life in ADPKD using the ADPKD-IS questionnaire

  Quality of life will be assessed using the ADPKD-IS questionnaire, which consists of 18 questions (1-5 Likert scale) in 3 domains (physical, emotional, fatigue) and 4 additional elements (guilt, sleep, size/shape of abdomen, urinary frequency/urgency). Unit of Measure: Total score per domain/element

  Interval of ≤ 3 months between screening and study visit

• Comparing pain between patients with ADPKD and healthy volunteers using the BPI-SF questionnaire

  The BPI-SF questionnaire consists of 9 questions, concerning both the intensity and impact of pain on daily functioning in the last 24 hours. This questionnaire will be conducted in patients with ADPKD and healthy volunteers.

  Interval of ≤ 3 months between screening and study visit

Secondary Outcomes (4)

• Correlation between QST and questionnaires

  Interval of ≤ 3 months between screening and study visit

• Differences in somatosensory phenotype depending on the disease stage of ADPKD

  Interval of ≤ 3 months between screening and study visit

• Differences in somatosensory phenotype depending on the sex of patients with ADPKD

  Interval of ≤ 3 months between screening and study visit

• Differences in pain and quality of life depending on the sex of patients with ADPKD

  Interval of ≤ 3 months between screening and study visit

Study Arms (2)

Patients with ADPKD

Patients with ADPKD will be included (≥ 12 years old). The somatosensory profile will be described using Quantitative Sensory Testing and questionnaires regarding pain and quality of life.

Other: Quantitative Sensory Testing; Other: Questionnaires regarding pain and quality of life

Healthy volunteers

Healthy volunteers will be included (≥ 12 years old), matched with the patient group based on age, sex and BMI. The somatosensory profile will be described using Quantitative Sensory Testing and the BPI-SF questionnaire.

Other: Quantitative Sensory Testing

Interventions

Quantitative Sensory Testing OTHER

We will perform QST on the dominant hand and lower back.

Healthy volunteers; Patients with ADPKD

Questionnaires regarding pain and quality of life OTHER

Questionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life.

Patients with ADPKD

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Pain

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jan de Hoon, MD, PhD, MSc

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flore Van Olmen, MSc

CONTACT

+32 016 34 22 01; flore.vanolmen@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 14, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)