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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05818995
Other study ID # LCYX-LX-20230101
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2024

Study information

Verified date April 2023
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chronic kidney disease (CKD), characterized as renal dysfunction, is recognized as a major public health problem with high morbidity and mortality worldwide. This study aimed to analyze the common drug use and combinations of different stages and types of CKD patients. The study is a multicenter retrospective study involving three hospitals. Investigators reviewed and analyzed all patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022. Chronic kidney disease was defined as eGFR less than 60 mL/min per 1·73 m(2) or the presence of albuminuria. The study selected seven types of drugs based on hospital electronic medical record data, including β Receptor blockers, angiotensin converting enzyme inhibitor blockers, angiotensin II receptors, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, and calcium channel blockers. Chi-square test, Mann-Whitney Wilcoxon test, and Kruskal Wallis test will be used for statistical analysis. The main purpose of this study is to provide evidence for promoting rational drug use in CKD patients by describing the drug use. The secondary purpose of the study is to explore the efficacy, safety and economy of SGLT-2 inhibitors in diabetes nephropathy (DN).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10000
Est. completion date June 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Visit time (based on admission time for inpatients) is from July 1, 2020 to June 30, 2022 2. Any diagnostic type of the patient's visit includes CKD related diagnostics 3. Age = 18 years old Exclusion Criteria: 1. Diagnosis includes malignant tumors 2. Diagnosis includes uremia, hemodialysis, or peritoneal dialysis 3. Diagnosis includes jaundice 4. Incomplete clinical data

Study Design


Intervention

Drug:
angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, ß Receptor blocker
Drug types: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, ß Receptor blockers Treatment prescription: medication alone or in combination Dose used: <standard dose, standard dose, >standard dose Frequency of administration: once a day, twice a day, three times a day.

Locations

Country Name City State
China Xiao Li,MD Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary eGFR The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by GFR staging. October , 2023
Primary albuminuria The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by albuminuria grading. October , 2023
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