Somatosensory Phenotyping of ADPKD

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: ADPKD; Pain

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

Study type: Observational

Funder types: Other

Identifiers

NCT06970028

S70540

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Patients with ADPKD

Description:

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.

Treatment:

Other: Questionnaires regarding pain and quality of life

Other: Quantitative Sensory Testing

Healthy volunteers

Description:

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.

Treatment:

Other: Quantitative Sensory Testing