Concept Elicitation and Patient Experience Mapping in SA-AKI

Concept Elicitation and Patient Experience Mapping in Sepsis-associated Acute Kidney Injury

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

Study Overview

• Status: Completed
• Conditions: Sepsis-associated Acute Kidney Injury

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults who have experienced SA-AKI. A subset of the interviews (50%-70%) will include a caregiver/care-partner in a dyad interview (a type of interview that involves two respondents). In addition, the study team targets for a minimum of 50% of participants that have been diagnosed with SA-AKI no longer than 5 years ago.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient perspective on sign, symptoms and impacts of SA-AKI	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	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 3 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: September 17, 2025
• First Posted (Estimated): September 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sepsis; Acute Kidney Injury
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Sepsis
• Other Study ID Numbers: CTIN816B12002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No