Acute Kidney InjuryNCT04879706
Proenkephalin A and Kidney Replacement Therapy
An observational study of Acute Kidney Injury, run by University of Giessen at 1 site in Germany.
Trial summary
Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- None planned
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2021to 21 Jan 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with severe AKI necessitating KRT at the University Hospital Giessen, Giessen, Germany
Who may be able to join
- Patients ≥18 years of age with AKI requiring KRT
Who cannot join
- Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73 m2
- Non-end stage renal disease with extracorporeal ultrafiltration due to diuretic- resistant fluid overload
- Decision to limit therapeutic interventions
- History of solid-organ transplants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proenkephalin A at Initiation and Discontinuation of Kidney Replacement Therapy
Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued.
The novel serum-biomarker proenkephalin A 119-159 (penkid) has been found to be strongly negatively correlated with measured GFR. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.
Read the detailed description
Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued. KRT is a complex and expensive therapy, with complications including catheter-associated infections, hemorrhage, hemodynamic instability, and potential delayed renal recovery.
The novel serum-biomarker proenkephalin A 119-159 (penkid) is a stable fragment derived from the precursor enkephalins, which are known as small endogenous opioid peptides and are produced throughout the human body, including the kidneys. Plasma concentrations of penkid have been found to be strongly negatively correlated with measured glomerular filtration rate. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.
- Conditions
- Acute Kidney Injury
- Being tested
- None planned
- 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.
None plannedOther
No intervention planned
| Study group | Role | What they receive |
|---|---|---|
| AKI necessitating KRT | Patients with AKI necessitating KRT Receives: Other: None planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penkid levels at KRT initiation
Serial assessment of penkid in patients undergoing KRT
Measured: Up to 2 weeks
Penkid levels at discontinuation of KRT
Serial assessment of penkid in patients undergoing KRT
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start9 Nov 2021
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Why it stopped: Poor patient enrollment
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Seeger, MD, Study director, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879706
- Sponsor's protocol ID
- AZ 37/21
- Status last verified
- Nov 2023
- First submitted
- 3 May 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim H, Hur M, Struck J, Bergmann A, Di Somma S. Proenkephalin Predicts Organ Failure, Renal Replacement Therapy, and Mortality in Patients With Sepsis. Ann Lab Med. 2020 Nov;40(6):466-473. doi: 10.3343/alm.2020.40.6.466. Epub 2020 Jun 17.
PubMed 32539302
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proenkephalin A at Initiation and Discontinuation of Kidney Replacement Therapy
- ClinicalTrials.gov ID
- NCT04879706
- Acronym / sponsor ID
- AZ 37/21
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor patient enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 10 May 2021 (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.
Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued.
The novel serum-biomarker proenkephalin A 119-159 (penkid) has been found to be strongly negatively correlated with measured GFR. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.
Detailed description
Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued. KRT is a complex and expensive therapy, with complications including catheter-associated infections, hemorrhage, hemodynamic instability, and potential delayed renal recovery.
The novel serum-biomarker proenkephalin A 119-159 (penkid) is a stable fragment derived from the precursor enkephalins, which are known as small endogenous opioid peptides and are produced throughout the human body, including the kidneys. Plasma concentrations of penkid have been found to be strongly negatively correlated with measured glomerular filtration rate. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKI necessitating KRT | – | Other: None plannedPatients with AKI necessitating KRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe AKI necessitating KRT at the University Hospital Giessen, Giessen, Germany
Key inclusion criteria (1 listed)
- Patients ≥18 years of age with AKI requiring KRT
Key exclusion criteria (5 listed)
- Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73 m2
- Non-end stage renal disease with extracorporeal ultrafiltration due to diuretic- resistant fluid overload
- Decision to limit therapeutic interventions
- History of solid-organ transplants
- Pregnancy
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 |
|---|---|---|
| None plannedNo intervention planned | Other | AKI necessitating KRT |
Primary outcome
Penkid levels at KRT initiation
Time frame: Up to 2 weeks
Serial assessment of penkid in patients undergoing KRT
Penkid levels at discontinuation of KRT
Time frame: Up to 2 weeks
Serial assessment of penkid in patients undergoing KRT
Results and safety
The study was stopped early (reason given: Poor patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 32539302Kim H, Hur M, Struck J, Bergmann A, Di Somma S. Proenkephalin Predicts Organ Failure, Renal Replacement Therapy, and Mortality in Patients With Sepsis. Ann Lab Med. 2020 Nov;40(6):466-473. doi: 10.3343/alm.2020.40.6.466. Epub 2020 Jun 17.
- 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.
Werner Seeger, MD study director
University of Giessen
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, run by University of Giessen 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: stopped early, as of the sponsor's last update on 1 Dec 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 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?
The study was stopped early (reason given: Poor patient enrollment). 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?
Penkid levels at KRT initiation (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. 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 NCT04879706, 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 1 Dec 2023.