Acute Kidney InjuryNCT06105229
Clinical Value of Plasma Humanin in Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI Researchers will compare humanin concentration in healthy people to see if humanin can be a novel marker for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: AKI patients from Guangdong Provincial People's Hospital from 2023 to May 2024
Who may be able to join
- Adult patients ≥ 18 years of age, male or female；
- Patients with AKI: Patients with acute kidney injury who meet the definition of KDIGO guidelines；
- Control group: from healthy physical examination population, physical examination blood routine, urine routine, liver function, kidney function, glycated hemoglobin and other indicators are normal；
- The patient's baseline medical record data is complete, including liver and kidney function, urine protein level, blood creatinine value, etc；
- Consent to enrollment and sign informed consent；
Who cannot join
- Age< 18 years；
- Baseline data were missing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangdong, Guangzhou, 510000
zhilian li, Doctor, 13580560903, lizhilian@gdph.org.cn
About this study
The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI Researchers will compare humanin concentration in healthy people to see if humanin can be a novel marker for predicting AKI
Read the detailed description
Acute Kidney Injury (AKI) is a clinically critical condition manifested by a sharp decline in kidney function, with approximately 13.3 million people diagnosed with AKI each year in hospital worldwide and associated with 1.7 million deaths. According to global multi-center research data, the total incidence of AKI in hospital is as high as 21%, and the incidence of acute kidney injury in hospitalized patients in China is 0.99%~11.6%. AKI increases the risk of long-term chronic kidney disease (CKD) and end-stage renal disease (ESRD), and has a very high long-term mortality rate. The diagnosis of AKI is mainly based on blood creatinine or urine output, and the current KDIGO criteria are used, but blood creatinine is a very insensitive indicator, so in the past 20 years, scholars have been exploring biological markers that are more sensitive than blood creatinine and urine output. Humanin is a mitochondrial polypeptide containing 24 amino acids. It was first identified in Alzheimer's disease patients in 2001. Studies have shown that Humanin has a strong mitochondrial protective effect in neurodegenerative diseases, cardiovascular diseases, diabetes, male infertility, cancer and other diseases, and its mechanism may be related to anti-apoptosis, anti-inflammation, regulation of autophagy and maintenance of mitochondrial homeostasis, because Humanin can function through autocrine, paracrine or endocrine forms, so it can be detected in the blood. Studies have shown that Humanin expression in serum or plasma of patients with diabetes and coronary heart disease is declined. In our previous study, the investigators found that Humanin was elevated in plasma in a mouse model of AKI with sepsis.
The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI
- Conditions
- Acute Kidney Injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury | Patients with AKI who meet KDIGO criteria | |
| Healthy controls | Healthy people without other underlying medical conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humanin concentration
Highest measured value used
Measured: one week
Serum creatinine concentration
Meets KDIGO's definition of AKI
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Aug 2022
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
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.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li zhilian, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105229
- Sponsor's protocol ID
- NO.GDREC2020278H
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Plasma Humanin in Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06105229
- Acronym / sponsor ID
- NO.GDREC2020278H
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Oct 2023 (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 goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI Researchers will compare humanin concentration in healthy people to see if humanin can be a novel marker for predicting AKI
Detailed description
Acute Kidney Injury (AKI) is a clinically critical condition manifested by a sharp decline in kidney function, with approximately 13.3 million people diagnosed with AKI each year in hospital worldwide and associated with 1.7 million deaths. According to global multi-center research data, the total incidence of AKI in hospital is as high as 21%, and the incidence of acute kidney injury in hospitalized patients in China is 0.99%~11.6%. AKI increases the risk of long-term chronic kidney disease (CKD) and end-stage renal disease (ESRD), and has a very high long-term mortality rate. The diagnosis of AKI is mainly based on blood creatinine or urine output, and the current KDIGO criteria are used, but blood creatinine is a very insensitive indicator, so in the past 20 years, scholars have been exploring biological markers that are more sensitive than blood creatinine and urine output. Humanin is a mitochondrial polypeptide containing 24 amino acids. It was first identified in Alzheimer's disease patients in 2001. Studies have shown that Humanin has a strong mitochondrial protective effect in neurodegenerative diseases, cardiovascular diseases, diabetes, male infertility, cancer and other diseases, and its mechanism may be related to anti-apoptosis, anti-inflammation, regulation of autophagy and maintenance of mitochondrial homeostasis, because Humanin can function through autocrine, paracrine or endocrine forms, so it can be detected in the blood. Studies have shown that Humanin expression in serum or plasma of patients with diabetes and coronary heart disease is declined. In our previous study, the investigators found that Humanin was elevated in plasma in a mouse model of AKI with sepsis.
The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury | – | –Patients with AKI who meet KDIGO criteria |
| Healthy controls | – | –Healthy people without other underlying medical conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AKI patients from Guangdong Provincial People's Hospital from 2023 to May 2024
Key inclusion criteria (5 listed)
- Adult patients ≥ 18 years of age, male or female；
- Patients with AKI: Patients with acute kidney injury who meet the definition of KDIGO guidelines；
- Control group: from healthy physical examination population, physical examination blood routine, urine routine, liver function, kidney function, glycated hemoglobin and other indicators are normal；
- The patient's baseline medical record data is complete, including liver and kidney function, urine protein level, blood creatinine value, etc；
- Consent to enrollment and sign informed consent；
Key exclusion criteria (2 listed)
- Age< 18 years；
- Baseline data were missing
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
Humanin concentration
Time frame: one week
Highest measured value used
Serum creatinine concentration
Time frame: one week
Meets KDIGO's definition of AKI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
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 Guangdong Provincial People's Hospital at 1 site in China.
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 2 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 27 Oct 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 China. 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?
Contact zhilian li, doctor (13580560903, lizhilian@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humanin concentration (time frame: one week). 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?
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 27 Oct 2023.