| NCT ID | NCT06970028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | ADPKD |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-09-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jan de Hoon, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT06970028 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying ADPKD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06970028 currently recruiting?
Yes, NCT06970028 is actively recruiting participants. Contact the research team at flore.vanolmen@uzleuven.be for enrollment information.
Where is the NCT06970028 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06970028 clinical trial?
NCT06970028 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Jan de Hoon, MD, PhD, MSc at UZ Leuven. The trial plans to enroll 150 participants.