ADPKDNCT06970028
Somatosensory Phenotyping of ADPKD
An observational study of ADPKD and Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- What is being tested?
- Quantitative Sensory Testing and Questionnaires regarding pain and quality of life
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Flore Van Olmen, MSc, +32 016 34 22 01, flore.vanolmen@uzleuven.be
About this study
Official title: Somatosensory Phenotyping of Patients With ADPKD Using Quantitative Sensory Testing and Questionnaires
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.
- Being tested
- Quantitative Sensory Testing, Questionnaires regarding pain and quality of life
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestingOther
We will perform QST on the dominant hand and lower back.
Questionnaires regarding pain and quality of lifeOther
Questionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quantitative Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: Interval of ≤ 3 months between screening and study visit
Secondary outcomes (4)
Correlation between QST and questionnaires
A correlation between QST results and results from the questionnaires will be assessed in patients with ADPKD.
Measured: Interval of ≤ 3 months between screening and study visit
Differences in somatosensory phenotype depending on the disease stage of ADPKD
Potential differences in somatosensory phenotype depending on the disease stage of patients with ADPKD (stage 1-5) will be evaluated using statistical analyses.
Measured: Interval of ≤ 3 months between screening and study visit
Differences in somatosensory phenotype depending on the sex of patients with ADPKD
Potential differences in the somatosensory phenotype (QST) of female and male patients with ADPKD will be evaluated using statistical analyses.
Measured: Interval of ≤ 3 months between screening and study visit
Differences in pain and quality of life depending on the sex of patients with ADPKD
Potential differences in pain and quality of life, described using questionnaires, of female and male patients with ADPKD will be evaluated using statistical analyses.
Measured: Interval of ≤ 3 months between screening and study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start9 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADPKDStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan de Hoon, MD, PhD, MSc, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970028
- Sponsor's protocol ID
- S70540
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Phenotyping of Patients With ADPKD Using Quantitative Sensory Testing and Questionnaires
- ClinicalTrials.gov ID
- NCT06970028
- Acronym / sponsor ID
- S70540
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ADPKD | – | Other: Quantitative Sensory Testing, Other: Questionnaires regarding pain and quality of lifePatients 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. |
| Healthy volunteers | – | Other: Quantitative Sensory TestingHealthy 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- Patients with ADPKD
- Subject is ≥ 12 years old.
- Subject is diagnosed with ADPKD.
- Healthy volunteers
- Subject is ≥ 12 years old.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory TestingWe will perform QST on the dominant hand and lower back. | Other | Healthy volunteers, Patients with ADPKD |
| Questionnaires regarding pain and quality of lifeQuestionnaires will be filled out by patients with ADPKD to evaluate pain and quality of life. | Other | Patients with ADPKD |
Primary outcome
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.
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
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)
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
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.
4 secondary outcomes
Correlation between QST and questionnaires
Time frame: Interval of ≤ 3 months between screening and study visit
Differences in somatosensory phenotype depending on the disease stage of ADPKD
Time frame: Interval of ≤ 3 months between screening and study visit
Differences in somatosensory phenotype depending on the sex of patients with ADPKD
Time frame: Interval of ≤ 3 months between screening and study visit
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan de Hoon, MD, PhD, MSc principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADPKD and Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flore Van Olmen, MSc (+32 016 34 22 01, flore.vanolmen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory phenotyping of ADPKD using Quantitative Sensory Testing (QST) (time frame: Interval of ≤ 3 months between screening and study visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.