Acute Kidney FailureNCT02470507
Immune Function in Acute Kidney Injury
An observational study of Acute Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The immune response to kidney damage during acute kidney injury (AKI) is an important contributor to the prolonged lack of renal function and progression of kidney injury. Most data related to intrarenal and interorgan pathways in AKI stem from animal research with sometimes conflicting results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- AKI
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalised patients
Who may be able to join
- Adult patients (≥ 18 years) admitted to the hospital (incl ICU) with one of the following:
- postoperative AKI II or III and systemic inflammation without sepsis
- systemic inflammation and normal renal function
- AKI II or III without systemic inflammation
- post-surgery with normal renal function and without SIRS or an infection
Who cannot join
- Renal transplant patients
- Patients on immunosuppressive drugs (except steroids)
- Patients with haematological malignancy
- Jehovah's witness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas Foundation Hospital
London, SE1 7EH
About this study
Official title: Evaluation of Immune Function in Patients With Acute Kidney Injury
The immune response to kidney damage during acute kidney injury (AKI) is an important contributor to the prolonged lack of renal function and progression of kidney injury. Most data related to intrarenal and interorgan pathways in AKI stem from animal research with sometimes conflicting results. Accurate evaluation of these processes in humans and identification of early diagnostic tools are critical for the development of strategies to prevent and attenuate AKI-related morbidity and mortality in patients.
The aim of this study is to evaluate immune function and miRNA expression in hospitalised patients with and without AKI.
Read the detailed description
Hypothesis:
An overriding pro-inflammatory immune response underlies AKI in humans which contributes to dysfunction of non-renal organs
Principal research question:
Is AKI in humans associated with a predominantly pro-inflammatory immune response?
Secondary research questions:
- Does AKI affect the phenotypic characterisation and function of neutrophils?
- Does severity of AKI lead to differences in phenotypic characterisation and function of neutrophils?
- What are the differences in cytokine profiles between AKI patients with and without systemic inflammation?
- What are the differences in cytokine profiles between AKI patients with systemic inflammation and patients with systemic inflammation without AKI?
- Is there a correlation between microRNA levels in patients with AKI and degree of AKI, renal recovery and patient outcome?
Study design:
Observational non-interventional study
Study population:
30 patients with AKI stage II or III * and systemic inflammation without sepsis 30 patients with AKI stage II or III * and no systemic inflammation 30 patients with systemic inflammation and normal renal function 30 patients after major surgery who do not have an infection, SIRS or AKI
- AKI will be defined by the KDIGO criteria
Primary outcome Detection of measurable phenotypic characteristics and function of leukocytes that are specific of patients with AKI.
Secondary outcomes:
- Differences in phenotypic characterisation and function of neutrophils between patients with AKI stage II and III.
- Differences in phenotypic characterisation and function of neutrophils between patients with and without AKI.
- Differences in cytokine profiles between patients with AKI and systemic inflammation and patients with AKI without systemic inflammation
- Differences in cytokine profiles between AKI patients with systemic inflammation and patients with systemic inflammation without AKI
- Correlation between microRNA levels in patients with AKI and renal recovery
- Correlation between microRNA levels in patients with AKI and patient outcome
- Differences in cytokine profiles between AKI patients without systemic inflammation and patients without AKI and without systemic inflammation / infection.
Statistical analysis:
For the analysis of laboratory variables that describe the immunological phenotype, standard statistical methods will be applied. 1) When the normal distribution assumption is met, groups will be compared using ANOVA and the corresponding contrasts for group by group comparisons; 2) In the absence of normality or for ordinal variables, Kruskal Wallis will be applied for multi-group comparisons, and Wilcoxon for two-groups analysis. We will apply multiple testing correction via Benjamini-Hochberg FDR control.
For the analysis of miRNA array data, we will first follow the protocol quality control measures appropriate for the platform of choice, and subsequently will carry out statistical analysis using the SAMr and LIMMA packages from Bioconductor, via the R software. Similarly, for the analysis of PCR data, the package HTqPCR from bioconductor will be used for quality control. Depending on the distribution of the final data, either non-parametric statistics, or a moderated t-test will be applied for statistical comparisons, with the corresponding multiple testing corrections as above.
- Conditions
- Acute Kidney Failure
- Being tested
- AKI
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKIOther
development of immune dysregulation and rise in inflammatory markers and activation of immune cells
| Study group | Role | What they receive |
|---|---|---|
| AKI with SIRS | Patients with AKI stage II or III and systemic inflammation without sepsis Receives: Other: AKI | |
| AKI without SIRS | Patients with AKI stage II or III and no systemic inflammation Receives: Other: AKI | |
| SIRS without AKI | Patients with systemic inflammation and normal renal function Receives: Other: AKI | |
| No SIRS and no AKI | Patients after major surgery who do not have an infection, SIRS or AKI Receives: Other: AKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic characteristics and function of leukocytes
Measured: 7 days
Secondary outcomes (7)
Differences in phenotypic characterisation and function of neutrophils between AKI stage II and III.
Measured: 7 days
Differences in phenotypic characterisation and function of neutrophils between AKI and no AKI
Measured: 7 days
Differences in cytokine profiles between AKI + SIRS and AKI without SIRS
Measured: 7 days
Differences in cytokine profiles between SIRS + AKI and SIRS without AKI
Measured: 7 days
Correlation between microRNA levels in patients with AKI and renal recovery
Correlation between microRNA levels in patients with AKI and patient outcome Differences in cytokine profiles between AKI patients without systemic inflammation and patients without AKI and without systemic inflammation / infection.
Measured: 7 days
Correlation between microRNA levels in patients with AKI and patient outcome
Differences in cytokine profiles between AKI patients without systemic inflammation and patients without AKI and without systemic inflammation / infection.
Measured: 7 days
Differences in cytokine profiles between AKI patients without SIRS and patients without AKI and without SIRS
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2013
- Primary completion1 Aug 2022
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Marlies Ostermann, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470507
- Sponsor's protocol ID
- CSP88220
- Status last verified
- Jan 2024
- First submitted
- 10 Jun 2015
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weller S, Varrier M, Ostermann M. Lymphocyte Function in Human Acute Kidney Injury. Nephron. 2017;137(4):287-293. doi: 10.1159/000478538. Epub 2017 Jun 30.
PubMed 28662513
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Function in Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02470507
- Acronym / sponsor ID
- CSP88220
- Conditions
- Acute Kidney Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2013 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jun 2015 (estimated)
- 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.
The immune response to kidney damage during acute kidney injury (AKI) is an important contributor to the prolonged lack of renal function and progression of kidney injury. Most data related to intrarenal and interorgan pathways in AKI stem from animal research with sometimes conflicting results. Accurate evaluation of these processes in humans and identification of early diagnostic tools are critical for the development of strategies to prevent and attenuate AKI-related morbidity and mortality in patients.
The aim of this study is to evaluate immune function and miRNA expression in hospitalised patients with and without AKI.
Detailed description
Hypothesis:
An overriding pro-inflammatory immune response underlies AKI in humans which contributes to dysfunction of non-renal organs
Principal research question:
Is AKI in humans associated with a predominantly pro-inflammatory immune response?
Secondary research questions:
- Does AKI affect the phenotypic characterisation and function of neutrophils?
- Does severity of AKI lead to differences in phenotypic characterisation and function of neutrophils?
- What are the differences in cytokine profiles between AKI patients with and without systemic inflammation?
- What are the differences in cytokine profiles between AKI patients with systemic inflammation and patients with systemic inflammation without AKI?
- Is there a correlation between microRNA levels in patients with AKI and degree of AKI, renal recovery and patient outcome?
Study design:
Observational non-interventional study
Study population:
30 patients with AKI stage II or III * and systemic inflammation without sepsis 30 patients with AKI stage II or III * and no systemic inflammation 30 patients with systemic inflammation and normal renal function 30 patients after major surgery who do not have an infection, SIRS or AKI
- AKI will be defined by the KDIGO criteria
Primary outcome Detection of measurable phenotypic characteristics and function of leukocytes that are specific of patients with AKI.
Secondary outcomes:
- Differences in phenotypic characterisation and function of neutrophils between patients with AKI stage II and III.
- Differences in phenotypic characterisation and function of neutrophils between patients with and without AKI.
- Differences in cytokine profiles between patients with AKI and systemic inflammation and patients with AKI without systemic inflammation
- Differences in cytokine profiles between AKI patients with systemic inflammation and patients with systemic inflammation without AKI
- Correlation between microRNA levels in patients with AKI and renal recovery
- Correlation between microRNA levels in patients with AKI and patient outcome
- Differences in cytokine profiles between AKI patients without systemic inflammation and patients without AKI and without systemic inflammation / infection.
Statistical analysis:
For the analysis of laboratory variables that describe the immunological phenotype, standard statistical methods will be applied. 1) When the normal distribution assumption is met, groups will be compared using ANOVA and the corresponding contrasts for group by group comparisons; 2) In the absence of normality or for ordinal variables, Kruskal Wallis will be applied for multi-group comparisons, and Wilcoxon for two-groups analysis. We will apply multiple testing correction via Benjamini-Hochberg FDR control.
For the analysis of miRNA array data, we will first follow the protocol quality control measures appropriate for the platform of choice, and subsequently will carry out statistical analysis using the SAMr and LIMMA packages from Bioconductor, via the R software. Similarly, for the analysis of PCR data, the package HTqPCR from bioconductor will be used for quality control. Depending on the distribution of the final data, either non-parametric statistics, or a moderated t-test will be applied for statistical comparisons, with the corresponding multiple testing corrections as above.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AKI with SIRS | – | Other: AKIPatients with AKI stage II or III and systemic inflammation without sepsis |
| AKI without SIRS | – | Other: AKIPatients with AKI stage II or III and no systemic inflammation |
| SIRS without AKI | – | Other: AKIPatients with systemic inflammation and normal renal function |
| No SIRS and no AKI | – | Other: AKIPatients after major surgery who do not have an infection, SIRS or AKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalised patients
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years) admitted to the hospital (incl ICU) with one of the following:
Key exclusion criteria (4 listed)
- Renal transplant patients
- Patients on immunosuppressive drugs (except steroids)
- Patients with haematological malignancy
- Jehovah's witness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKIdevelopment of immune dysregulation and rise in inflammatory markers and activation of immune cells | Other | AKI with SIRS, AKI without SIRS, No SIRS and no AKI, SIRS without AKI |
Primary outcome
Phenotypic characteristics and function of leukocytes
Time frame: 7 days
7 secondary outcomes
Differences in phenotypic characterisation and function of neutrophils between AKI stage II and III.
Time frame: 7 days
Differences in phenotypic characterisation and function of neutrophils between AKI and no AKI
Time frame: 7 days
Differences in cytokine profiles between AKI + SIRS and AKI without SIRS
Time frame: 7 days
Differences in cytokine profiles between SIRS + AKI and SIRS without AKI
Time frame: 7 days
Correlation between microRNA levels in patients with AKI and renal recovery
Time frame: 7 days
Correlation between microRNA levels in patients with AKI and patient outcome
Time frame: 7 days
Differences in cytokine profiles between AKI patients without SIRS and patients without AKI and without SIRS
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 28662513Weller S, Varrier M, Ostermann M. Lymphocyte Function in Human Acute Kidney Injury. Nephron. 2017;137(4):287-293. doi: 10.1159/000478538. Epub 2017 Jun 30.
- 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.
Marlies Ostermann principal investigator
Guy's and St Thomas' NHS Foundation Trust
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 Acute Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2024. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Phenotypic characteristics and function of leukocytes (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470507, which also lists 1 linked publication.
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 23 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.