Acute Kidney InjuryKRAKILNCT04551391
Kidney Recovery After Acute Kidney Injury - Longitudinal Study
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
The endothelin (ET) system is an active target in human Acute Kidney Injury (AKI). Our primary hypothesis is that the circulating blood concentration of ET will be higher in patients with AKI than in matched controls. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Diseases
- What is being tested?
- Blood and urine sampling
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2020to 1 Nov 2023
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: (i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI
Who may be able to join
- Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as:
- Previous (within 3 years) eGFR >45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND
- Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND
- Increasing creatinine >= 27μmol/L above index value within 48 hours
- The control group (N=50) inclusion criteria are:
- Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR > 60)
Show all 10Show fewer
- This group will be recruited contemporaneously with, and matched to, AKI participants by:
- Age (± 5 years)
- Sex
- AKI aetiology (ischaemic, infected, nephrotoxic) 4 (i) History of diabetes or not AND/OR (ii) History of cardiovascular disease or not
Who cannot join
- Inability to provide informed consent
- Prisoners
- Pregnancy or breast feeding
- Evidence of CKD
Trial locations and contacts
1 site in 1 country.
About this study
The endothelin (ET) system is an active target in human Acute Kidney Injury (AKI).
Our primary hypothesis is that the circulating blood concentration of ET will be higher in patients with AKI than in matched controls.
Read the detailed description
Acute kidney injury (AKI) is a major health problem being both common and costly. It affects ~20% of hospital inpatients and consumes ~1% of the annual NHS budget. AKI occurs following a diverse range of insults, commonly ischaemia-reperfusion injury (IRI) but also sepsis and drug toxicity. Therapies for AKI are currently supportive and short-term mortality remains high, with ~2 million deaths per year worldwide. In those who survive an episode of AKI, 30% are left with chronic kidney disease (CKD). The remaining 70% that recover full renal function are at ~28-fold increased risk of ultimately developing CKD. This risk is even greater in elderly patients. Importantly, CKD is strongly and independently associated with incident cardiovascular disease (CVD), and together these exert a global socioeconomic burden.
The recognition that AKI and CKD are linked is recent and the molecular pathways that control the transition from acute injury to chronic disease are not well defined. Currently, there are no specific treatments that reduce the risk of progressing to CKD after AKI. Thus, there is an unmet need for therapies that will prevent the transition from AKI to CKD and reduce the cardiovascular burden associated with both. Our preliminary investigations (not yet published) in humans and mice suggest that AKI causes sustained activation of the endothelin (ET) system to the long-term detriment of renal and systemic haemodynamic function. These pilot data form the basis of our project that seeks to determine whether the ET system is active in patients with AKI and, thus, represents a potential target for therapeutic intervention.
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases
- Being tested
- Blood and urine sampling
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samplingOther
Also called retinal opticla coherence tomography
Retinal OCT is a novel, non-invasive method for cross-sectionally imaging the eye's retina and choroid
| Study group | Role | What they receive |
|---|---|---|
| Case | (i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as:
* Previous (within 3 years) eGFR >45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND
* Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND
* Increasing creatinine >= 27μmol/L above index value within 48 hours Receives: Other: Blood and urine sampling | |
| Control | (i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR > 60).
This group will be recruited contemporaneously with, and matched to, AKI participants by:
1. Age (± 5 years)
2. Sex
3. AKI aetiology (ischaemic, infected, nephrotoxic) 4 (i) History of diabetes or not AND/OR (ii) History of cardiovascular disease or not Receives: Other: Blood and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To primary outcome aims to measure whether circulating ET is higher in patients with AKI than in matched controls.
as above
Measured: 3 years
Secondary outcomes (1)
The secondary outcome aims to measure differences in urine ET between patients with AKI and matched controls AKI patients that do not fully recover renal function within 90 days will have the highest concentrations of blood and urine ET.
as above
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start7 Jan 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551391
- Sponsor's protocol ID
- ss
- Other IDs
- MR/S01053X/1
- Acronym
- KRAKIL
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Recovery After Acute Kidney Injury - Longitudinal Study
- ClinicalTrials.gov ID
- NCT04551391
- Acronym / sponsor ID
- KRAKIL / ss
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- University of Edinburgh
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 16 Sep 2020 (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.
The endothelin (ET) system is an active target in human Acute Kidney Injury (AKI).
Our primary hypothesis is that the circulating blood concentration of ET will be higher in patients with AKI than in matched controls.
Detailed description
Acute kidney injury (AKI) is a major health problem being both common and costly. It affects ~20% of hospital inpatients and consumes ~1% of the annual NHS budget. AKI occurs following a diverse range of insults, commonly ischaemia-reperfusion injury (IRI) but also sepsis and drug toxicity. Therapies for AKI are currently supportive and short-term mortality remains high, with ~2 million deaths per year worldwide. In those who survive an episode of AKI, 30% are left with chronic kidney disease (CKD). The remaining 70% that recover full renal function are at ~28-fold increased risk of ultimately developing CKD. This risk is even greater in elderly patients. Importantly, CKD is strongly and independently associated with incident cardiovascular disease (CVD), and together these exert a global socioeconomic burden.
The recognition that AKI and CKD are linked is recent and the molecular pathways that control the transition from acute injury to chronic disease are not well defined. Currently, there are no specific treatments that reduce the risk of progressing to CKD after AKI. Thus, there is an unmet need for therapies that will prevent the transition from AKI to CKD and reduce the cardiovascular burden associated with both. Our preliminary investigations (not yet published) in humans and mice suggest that AKI causes sustained activation of the endothelin (ET) system to the long-term detriment of renal and systemic haemodynamic function. These pilot data form the basis of our project that seeks to determine whether the ET system is active in patients with AKI and, thus, represents a potential target for therapeutic intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Blood and urine sampling(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as: * Previous (within 3 years) eGFR >45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND * Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND * Increasing creatinine >= 27μmol/L above index value within 48 hours |
| Control | – | Other: Blood and urine sampling(i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR > 60). This group will be recruited contemporaneously with, and matched to, AKI participants by: 1. Age (± 5 years) 2. Sex 3. AKI aetiology (ischaemic, infected, nephrotoxic) 4 (i) History of diabetes or not AND/OR (ii) History of cardiovascular disease or not |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- (i) Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI
Key inclusion criteria (10 listed)
- Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Diagnosis of AKI determined as:
- Previous (within 3 years) eGFR >45 mL/min/1.73m2 OR no history of kidney disease if no recent (within 3 years) blood results available AND
- Elevated creatinine over 1.5 x previous result OR over 150 μmol/L if no previous value AND
- Increasing creatinine >= 27μmol/L above index value within 48 hours
- Adult aged 16 or over; (ii) Ability to provide informed consent; (iii) Admitted to hospital without AKI: (eGFR > 60)
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Prisoners
- Pregnancy or breast feeding
- Evidence of CKD
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 |
|---|---|---|
| Blood and urine samplingAlso: retinal opticla coherence tomographyRetinal OCT is a novel, non-invasive method for cross-sectionally imaging the eye's retina and choroid | Other | Case, Control |
Primary outcome
To primary outcome aims to measure whether circulating ET is higher in patients with AKI than in matched controls.
Time frame: 3 years
as above
1 secondary outcome
The secondary outcome aims to measure differences in urine ET between patients with AKI and matched controls AKI patients that do not fully recover renal function within 90 days will have the highest concentrations of blood and urine ET.
Time frame: 3 YEARS
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 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury and Chronic Kidney Diseases, run by NHS Lothian 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 10 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 15 Nov 2023. 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?
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?
To primary outcome aims to measure whether circulating ET is higher in patients with AKI than in matched controls. (time frame: 3 years). 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 15 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.