Therapeutic Drug Use for CKD Patients

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Xiao Li,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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 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 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 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 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 Frequency of administration: once a day, twice a day, three times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Drug safety; Drug effectiveness; Diabetes nephropathy; Drug economics
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Serine Proteinase Inhibitors; Vasoconstrictor Agents; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Enzyme Inhibitors; Calcium Channel Blockers; Angiotensin II; Giapreza; Angiotensinogen; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Glucagon-Like Peptide-1 Receptor Agonists
• Other Study ID Numbers: LCYX-LX-20230101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No