Sepsis-associated Acute Kidney InjuryNCT07180238
Concept Elicitation and Patient Experience Mapping in SA-AKI
An observational study of Sepsis-associated Acute Kidney Injury, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis-associated Acute Kidney Injury
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: 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)
Read the 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.
- Conditions
- Sepsis-associated Acute Kidney Injury
- Keywords
- Sepsis, Acute Kidney Injury
- Medical subject headings
- Sepsis, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 months
Secondary outcomes (1)
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
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 May 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis-associated Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180238
- Sponsor's protocol ID
- CTIN816B12002
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concept Elicitation and Patient Experience Mapping in Sepsis-associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07180238
- Acronym / sponsor ID
- CTIN816B12002
- Conditions
- Sepsis-associated Acute Kidney Injury
- Keywords
- Sepsis, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient perspective on sign, symptoms and impacts of SA-AKI
Time frame: 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
1 secondary outcome
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
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis-associated Acute Kidney Injury, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient perspective on sign, symptoms and impacts of SA-AKI (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.