Therapeutic Drug Use for CKD Patients

Active, not recruiting

• Conditions: Chronic Kidney Disease
• Interventions: Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker

• Registration Number: NCT05818995
• Lead Sponsor: Qianfoshan Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-23
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-19
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10000

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

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Exclusion Criteria

1. Diagnosis includes malignant tumors
2. Diagnosis includes uremia, hemodialysis, or peritoneal dialysis
3. Diagnosis includes jaundice
4. Incomplete clinical data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD G2	angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker	GFR 60\~89 mL/(min·1.73m2)
CKD G1	angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker	GFR ≥90 mL/(min·1.73m2)
CKD G3	angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker	GFR 30\~59 mL/(min·1.73m2)
CKD G4	angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker	GFR 15\~29 mL/(min·1.73m2)
CKD G5	angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker	GFR \<15 mL/(min·1.73m2)

Primary Outcome Measures

Name	Time	Method
eGFR	October , 2023	The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by GFR staging.
albuminuria	October , 2023	The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by albuminuria grading.

Trial Locations

Locations (1)

Xiao Li，MD; 🇨🇳 Jinan, Shandong, China