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NCT Number: NCT06970028

Somatosensory Phenotyping of ADPKD

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative Sensory Testing

Other

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

Questionnaires regarding pain and quality of life

Other

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

Primary outcomes

  1. Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST)

    Time frame: Interval of ≤ 3 months between screening and study visit

    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.

  2. Describing pain in ADPKD using the ADPKD-PDS questionnaire

    Time frame: Interval of ≤ 3 months between screening and study visit

    (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

  3. Describing neuropathic pain in ADPKD using the DN4 questionnaire

    Time frame: Interval of ≤ 3 months between screening and study visit

    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)

  4. Describing quality of life in ADPKD using the ADPKD-IS questionnaire

    Time frame: Interval of ≤ 3 months between screening and study visit

    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

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

    Time frame: Interval of ≤ 3 months between screening and study visit

    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.

Secondary outcomes

  1. Correlation between QST and questionnaires

    Time frame: Interval of ≤ 3 months between screening and study visit

    A correlation between QST results and results from the questionnaires will be assessed in patients with ADPKD.

  2. Differences in somatosensory phenotype depending on the disease stage of ADPKD

    Time frame: Interval of ≤ 3 months between screening and study visit

    Potential differences in somatosensory phenotype depending on the disease stage of patients with ADPKD (stage 1-5) will be evaluated using statistical analyses.

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

    Time frame: Interval of ≤ 3 months between screening and study visit

    Potential differences in the somatosensory phenotype (QST) of female and male patients with ADPKD will be evaluated using statistical analyses.

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

    Time frame: Interval of ≤ 3 months between screening and study visit

    Potential differences in pain and quality of life, described using questionnaires, of female and male patients with ADPKD will be evaluated using statistical analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

Flore Van Olmen, MSc

CONTACT

[email protected]

+32 016 34 22 01

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Somatosensory Phenotyping of Patients With ADPKD Using Quantitative Sensory Testing and Questionnaires

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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