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Evaluation of clinical effect of ß trace protein in evaluating glomerular filtration

Evaluation of clinical effect of ß trace protein in evaluating glomerular filtration

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038473
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

Gold Standard:99mTc-DTPA detect glomerular filtration rate
Index test:ß&#32
protein
Scattering&#32
nephelometry
protein&#32
analyzer:&#32
BN&#32
system
diagnostic&#32
Ltd

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. All the selected samples are required to have complete relevant information, including age, gender, sample collection date, etc. 2. The age of patients should be 18 to 80 years old. 3. Agree to participate in the clinical project of patients, and voluntarily sign informed consent. 4. The EGFR of the inclusion criteria was calculated by CKD-EPI formula. 5. In CKD group, GFR was detected with gold standard 99mTc DTPA. 1) Sample of apparent healthy people 2) G1-2 sample 3) G3 sample 4) G4 sample 5) G5 non dialysis patient sample 6) G5 dialysis patient samples

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for all samples: (1) Samples with severe hemolysis, turbidity and jaundice; (2) Samples contaminated by microorganisms; (3) Samples that do not meet the requirements of sample collection and processing; (4) The sample size is not enough to complete the test; (5) The sample storage does not meet the requirements of the specification; (6) The samples of the same subject were repeated into the group, and only one sample was collected (if the researcher needs to track the patient's condition, the patient can be repeatedly sampled and tested); (7) Other researchers judged the samples that did not meet the inclusion criteria. 2. For samples, the following exclusion criteria should be followed: (1) Clear the history of malignant tumor; (2) The patients had definite urinary tract obstruction or retention difficulty; (3) Acute attack of ischemic heart disease (in accordance with the diagnosis of acute coronary syndrome) or heart failure (according to New York grade III or IV); (4) Patients with liver cirrhosis were diagnosed clearly; (5) Known to be pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
ß trace protein;glomerular filtration rate;

Countries

China

Contacts

Public ContactWang Juan

Shanghai General Hospital

wjuan920@126.com+86 18621570060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026