Concept Elicitation and Patient Experience Mapping in SA-AKI

Recruiting

• Conditions: Sepsis-associated Acute Kidney Injury

• Registration Number: NCT07180238
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI)

Detailed Description

The purpose of this study is to elicit concepts of interests in patients who experienced SA-AKI. The study also aims to map experiences from patient and caregiver perspectives, including treatment pathways and barriers to SA-AKI treatment, the burden of SA-AKI and unmet needs, and the disease's humanistic, societal, and economic impacts. This study is a cross-sectional, non-interventional qualitative interview study of up to 30 people who have experienced SA-AKI from the US and Germany. Participants will be screened for eligibility, provide consent, and complete a virtual, hybrid 60-minute semi-structured concept elicitation (CE) and patient experience interview. Transcripts will be reviewed by analysts and analysed according to a qualitative analysis plan including a thematic analysis of the coded transcripts. This is a minimal risk study. All information will be kept confidential, and information will be stored on a secure network which is only accessible to the study team.

Study Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Potential participants who were diagnosed with SA-AKI (KDIGO stage I, II or III) must meet the following eligibility criteria:

• ≥18 to ≤ 85 years of age
• First diagnosis of SA-AKI at least 6 months prior to screening date, but no more than 10 years
• Admitted due to sepsis and/or AKI to intensive care unit (ICU), intermediate care unit (IMCU), or high-dependency care unit, or developed sepsis and/or AKI during their inpatient hospital stay.
• Resident of country of study (US or Germany)
• Access to computer, tablet, or smartphone with internet connection
• Willing to participate in an audio recorded interview

Participants will be required to present confirmation of diagnosis (COD) rather than relying on a self-reported diagnosis. Sepsis and AKI diagnoses will be confirmed through one of the following:

• Copy of medical records (e.g., portable document format [PDF] file of electronic health record)
• Physician confirmation of diagnosis of sepsis and AKI (post-sepsis)

Potential caregiver participants must meet the following criteria:

• ≥18 to ≤ 85 years of age
• Primary caregiver/care-partner for eligible participant who experienced SA-AKI
• Resident of country of study (US or Germany)
• Access to computer, tablet, or smartphone with internet connection
• Willing to participate in an audio recorded interview

Exclusion Criteria

Potential participants are not eligible if they meet any of the following criteria:

• Less than age of majority in locality (Participant is not considered an adult in their country or region)
• Not willing to participate in an audio recorded interview
• Not able to participate in the interview or complete required study surveys, based on the discretion of the study team

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient perspective on sign, symptoms and impacts of SA-AKI	Up to 3 months	A 60-min qualitative interview will be conducted and transcripts will be coded to assess which signs, symptoms and impacts of SA-AKI have been experienced by the participant

Secondary Outcome Measures

Name	Time	Method
Patient experiences on treatment pathways and barriers to SA-AKI treatment, the burden of SA-AKI and unmet needs, and the humanistic, societal, and economic impacts	Up to 3 months	A 60-min qualitative interview will be conducted and transripts will be coded to assess the treatment pathways and barriers to SA-AKI treatment, the burden of SA-AKI and unmet needs, and the humanistic, societal, and economic impacts

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 East Hanover, New Jersey, United States