Therapeutic Drug Use for CKD Patients

NCT05818995 | Unknown

• 1 other identifier: LCYX-LX-20230101
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; Diabetes nephropathy; Drug effectiveness; Drug safety; Drug economics

Outcome Measures

Primary Outcomes (2)

• eGFR

  The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by GFR staging.

  October , 2023

• albuminuria

  The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by albuminuria grading.

  October , 2023

Study Arms (5)

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

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

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

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

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

Interventions

angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker DRUG

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 G1; CKD G2; CKD G3; CKD G4; CKD G5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022

You may qualify if:

• 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

You may not qualify if:

• Diagnosis includes malignant tumors
• Diagnosis includes uremia, hemodialysis, or peritoneal dialysis
• Diagnosis includes jaundice
• Incomplete clinical data

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Xiao Li，MD

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetic Nephropathies

Interventions

Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Glucagon-Like Peptide-1 Receptor Agonists; Sodium-Glucose Transporter 2 Inhibitors; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 19, 2023
• Study Start: July 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2023-04

Locations

CN (1)