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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Germany1 site
  • Klinik für Anästhesiologie

    Düsseldorf, 40225

Other trials in Germany

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted8 May 2020
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2020 (estimated)

Resources

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)
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

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.

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