Chronic Kidney DiseaseNCT05818995
Therapeutic Drug Use for CKD Patients
An observational study of Chronic Kidney Disease, run by Qianfoshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022
Who may be able to join
- 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
Who cannot join
- Diagnosis includes malignant tumors
- Diagnosis includes uremia, hemodialysis, or peritoneal dialysis
- Diagnosis includes jaundice
- Incomplete clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Chronic Kidney Disease
- Being tested
- angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker
- Keywords
- Chronic kidney disease, Diabetes nephropathy, Drug effectiveness, Drug safety, Drug economics
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CKD G1 | GFR ≥90 mL/(min·1.73m2) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by GFR staging.
Measured: October , 2023
albuminuria
The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by albuminuria grading.
Measured: October , 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Jul 2022
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Li，MD, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818995
- Sponsor's protocol ID
- LCYX-LX-20230101
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Use in Patients With Chronic Kidney Disease (CKD): a Multicenter Retrospective Real-world Study
- ClinicalTrials.gov ID
- NCT05818995
- Acronym / sponsor ID
- LCYX-LX-20230101
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Diabetes nephropathy, Drug effectiveness, Drug safety, Drug economics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CKD G1 | – | Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerGFR ≥90 mL/(min·1.73m2) |
| CKD G2 | – | Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerGFR 60~89 mL/(min·1.73m2) |
| CKD G3 | – | Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerGFR 30~59 mL/(min·1.73m2) |
| CKD G4 | – | Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerGFR 15~29 mL/(min·1.73m2) |
| CKD G5 | – | Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerGFR <15 mL/(min·1.73m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosis includes malignant tumors
- Diagnosis includes uremia, hemodialysis, or peritoneal dialysis
- Diagnosis includes jaundice
- Incomplete clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockerDrug 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. | Drug | CKD G1, CKD G2, CKD G3, CKD G4, CKD G5 |
Primary outcome
eGFR
Time frame: October , 2023
The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by GFR staging.
albuminuria
Time frame: October , 2023
The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by albuminuria grading.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: October , 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.