NCT06105229

Brief 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 predicting AKI

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

October 7, 2023

Last Update Submit

October 23, 2023

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

  • Humanin concentration

    Highest measured value used

    one week

  • Serum creatinine concentration

    Meets KDIGO's definition of AKI

    one week

Study Arms (2)

Acute kidney injury

Patients with AKI who meet KDIGO criteria

Healthy controls

Healthy people without other underlying medical conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AKI patients from Guangdong Provincial People's Hospital from 2023 to May 2024

You may qualify if:

  • 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；

You may not qualify if:

  • Age\< 18 years；
  • Baseline data were missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangdong, Guangzhou, 510000, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

zhilian li, doctor

CONTACT

13580560903lizhilian@gdph.org.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 27, 2023

Study Start

August 1, 2022

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

CN(1)