Markers in Plasma and UrineNCT04381156
MicroRNAs in Renal Recovery - Pilot Study
An observational study of Markers in Plasma and Urine, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
In this Pilot study, the potential of noncoding RNAs in renal recovery from acute kidney injury will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Markers in Plasma and Urine
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Critically ill patients with AKI
Who may be able to join
- AKI stage 2 or 3
Who cannot join
- kidney transplantation
- eGFR < 30 ml/Min
- dialysis within last 90 days
- chronic dialysis
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Involvement of microRNAs in the Recovery From Acute Kidney Injury
In this Pilot study, the potential of noncoding RNAs in renal recovery from acute kidney injury will be evaluated.
Read the detailed description
Acute kidney injury (AKI) occurs in almost 50% of patients treated in intensive care units. AKI mainly occurs after sepsis, acute ischemia, nephrotoxicity or hypoxia and leads to severe damage of the kidney and to an increased risk of mortality. The diagnosis of AKI is currently based on creatinine, urea and diuresis. Yet, novel markers may improve the accuracy of this diagnosis at an early stage of the disease, thereby allowing for early prevention and therapy, ultimately leading to a reduction of the need for renal replacement therapy and decreased mortality. Several potential biomarkers have been examined in the context of AKI in the last years [e. g. Cystatin C, a cysteine protease inhibitor, NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury molecule 1), and IGFBP7 (insulin like growth factor binding protein 7) and TIMP-2 (tissue inhibitor of metalloproteinase 2)].
These biomarkers may help to identify AKI earlier and more reliable in the future.
However, recovery of renal function during/after AKI is not predictable with the classical biomarkers creatinine and urea. Only a few studies have analyzed the potential of several new biomarkers in the prediction of renal recovery during AKI including urinary hepatocyte growth factor (uHGF), urinary IGFBP- 7 and TIMP-2 or NGAL. Still, their ability to predict renal recovery remains unclear and in clinical practice, recovery of renal function is estimated empirically including the decision to discontinue renal replacement therapy. In a consensus statement from 2017 on behalf of the Acute Disease Quality Initiative Workgroup 16 it is stated that more research is needed to "determine optimal methods to assess functional recovery and identify novel biomarker(s) [...] that can inform ongoing injury and repair in AKD".
In the ncRNA in renal recovery study we therefore aim to analyze the potential of microRNAs (miRNAs) and circular RNA (circRNAs) in predicting recovery of renal function in critically ill patients suffering from AKI. Non-coding RNAs emerged during the past few years as important regulatory molecules that allow a fine-tuning of gene expression and protein synthesis. This regulation is necessary to maintain homeostasis and its dysregulation is often associated with disease development. Non-coding RNAs are present in the kidney and in body fluids and their expression is modulated during AKI and their potential as biomarkers in various diseases has been shown. As ncRNAs are involved in injury and repair of kidneys, they may represent an interesting class of molecules with a potential as biomarkers and therapeutic targets in recovery from AKI.
Blood and urine samples will be collected at 4 different time points (day 0, day 1, day 2 and day 7). Plasma miRNAs will be screened for differential miRNA expression by next generation sequencing (5 patients with early recovery versus 5 patients with no signs of recovery). Differentially expressed miRNAs will then be analyzed by qPCR in plasma and urine.
The proposed study is aimed to better understand the pathophysiological basis of recovery from AKI and may form the basis of further studies for biomarker and therapeutics research in renal recovery.
- Conditions
- Markers in Plasma and Urine
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of ncRNAs as markers in renal recovery from AKI
Observation
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Markers in Plasma and UrineStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381156
- Sponsor's protocol ID
- 6138
- Status last verified
- Jul 2020
- First submitted
- 7 May 2020
- Last updated
- 13 Jul 2020
- Results posted
- 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 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Involvement of microRNAs in the Recovery From Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04381156
- Acronym / sponsor ID
- 6138
- Conditions
- Markers in Plasma and Urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 May 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.
In this Pilot study, the potential of noncoding RNAs in renal recovery from acute kidney injury will be evaluated.
Detailed description
Acute kidney injury (AKI) occurs in almost 50% of patients treated in intensive care units. AKI mainly occurs after sepsis, acute ischemia, nephrotoxicity or hypoxia and leads to severe damage of the kidney and to an increased risk of mortality. The diagnosis of AKI is currently based on creatinine, urea and diuresis. Yet, novel markers may improve the accuracy of this diagnosis at an early stage of the disease, thereby allowing for early prevention and therapy, ultimately leading to a reduction of the need for renal replacement therapy and decreased mortality. Several potential biomarkers have been examined in the context of AKI in the last years [e. g. Cystatin C, a cysteine protease inhibitor, NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury molecule 1), and IGFBP7 (insulin like growth factor binding protein 7) and TIMP-2 (tissue inhibitor of metalloproteinase 2)].
These biomarkers may help to identify AKI earlier and more reliable in the future.
However, recovery of renal function during/after AKI is not predictable with the classical biomarkers creatinine and urea. Only a few studies have analyzed the potential of several new biomarkers in the prediction of renal recovery during AKI including urinary hepatocyte growth factor (uHGF), urinary IGFBP- 7 and TIMP-2 or NGAL. Still, their ability to predict renal recovery remains unclear and in clinical practice, recovery of renal function is estimated empirically including the decision to discontinue renal replacement therapy. In a consensus statement from 2017 on behalf of the Acute Disease Quality Initiative Workgroup 16 it is stated that more research is needed to "determine optimal methods to assess functional recovery and identify novel biomarker(s) [...] that can inform ongoing injury and repair in AKD".
In the ncRNA in renal recovery study we therefore aim to analyze the potential of microRNAs (miRNAs) and circular RNA (circRNAs) in predicting recovery of renal function in critically ill patients suffering from AKI. Non-coding RNAs emerged during the past few years as important regulatory molecules that allow a fine-tuning of gene expression and protein synthesis. This regulation is necessary to maintain homeostasis and its dysregulation is often associated with disease development. Non-coding RNAs are present in the kidney and in body fluids and their expression is modulated during AKI and their potential as biomarkers in various diseases has been shown. As ncRNAs are involved in injury and repair of kidneys, they may represent an interesting class of molecules with a potential as biomarkers and therapeutic targets in recovery from AKI.
Blood and urine samples will be collected at 4 different time points (day 0, day 1, day 2 and day 7). Plasma miRNAs will be screened for differential miRNA expression by next generation sequencing (5 patients with early recovery versus 5 patients with no signs of recovery). Differentially expressed miRNAs will then be analyzed by qPCR in plasma and urine.
The proposed study is aimed to better understand the pathophysiological basis of recovery from AKI and may form the basis of further studies for biomarker and therapeutics research in renal recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with AKI
Key inclusion criteria (1 listed)
- AKI stage 2 or 3
Key exclusion criteria (5 listed)
- kidney transplantation
- eGFR < 30 ml/Min
- dialysis within last 90 days
- chronic dialysis
- pregnancy
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
Predictive value of ncRNAs as markers in renal recovery from AKI
Time frame: 1 yr
Observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- 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 Markers in Plasma and Urine, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jul 2020. 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 Germany. 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?
Results are not available in the source record.
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?
Predictive value of ncRNAs as markers in renal recovery from AKI (time frame: 1 yr). 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 13 Jul 2020.