A Study Of Concept Elicitation And Cognitive Debriefing Interviews For ADPKD

Overview

About this study

The purpose of this qualitative interview study is to explore adult participants’ experiences of living with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This includes identifying signs, symptoms, and impacts of the disease that are relevant and most bothersome to these patients through concept elicitation (CE) interviews. This study also aims to assess the appropriateness of instruments for measuring symptom burden and impact in people with ADPKD through cognitive debriefing (CD) interviews. The instruments that will be debriefed in this study are planned to be included in a Phase 3 trial investigating the benefits of a novel once-monthly subcutaneous treatment to slow kidney function decline in adults at risk of rapidly progressing ADPKD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient is 18 to 80 years of age.

  • Patient has a medically confirmed diagnosis of ADPKD via COD

    • ADPKD Mayo Class: 1B-1E

    • eGFR = 30 – 90 ml/min/1.73m2

  • Patient is willing and capable of providing informed consent to participate in the study and is willing to sign the consent form.

  • Participants must self-report, via the online screener, either (a) not having experienced any lifetime ADPKD-related pain (Group 1: No Pain Cohort) or (b) having experienced ADPKD-related pain within the past 4 weeks/last month (Group 2: Pain Cohort)

    Patient provides consent via the ICF, including consent to be audio recorded

    Patient is physically, cognitively, and linguistically able to participate in one or two one-on-one, up to 80-minute telephone interviews in English using an internet-enabled computer or other device (such as a tablet) with screensharing / screen-viewing capabilities.

    Patient is a fluent English speaker able to read, write, and fully understand the English language.

    Patient resides in the US.

Exclusion Criteria:

  • In the opinion of the site (based on the information shared), the participant has any medical condition or disorder that could compromise their ability to:

  • Provide consent to participate.

  • Successfully participate in a web-based interview and provide meaningful information about their experience.

  • Have another chronic condition which could confound the results of this study (causes pain)

  • Currently participating in a clinical trial or has participated in a clinical trial within the last 30 days at the time of recruitment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/20/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Neera Dahl

Open for enrollment

Contact information:

Neera Dahl

(507) 284-4083

Dahl.Neera@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Fouad Chebib

Open for enrollment

Contact information:

Fouad Chebib

(904) 956-8989

Chebib.Fouad@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20597194

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