Therapeutic Drug Use for CKD Patients

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05818995

Collaborator

(none)

10,000

Enrollment

Location

Anticipated Duration (Months)

417

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Therapeutic Drug Use in Patients With Chronic Kidney Disease (CKD): a Multicenter Retrospective Real-world Study

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Visit time (based on admission time for inpatients) is from July 1, 2020 to June 30, 2022
Any diagnostic type of the patient's visit includes CKD related diagnostics
Age ≥ 18 years old