Chronic Kidney DiseasesNCT05242055
Integrated Diagnosis and Treatment of CKD on Outcomes
An observational study of Chronic Kidney Diseases and Hypertension, run by Capital Medical University at 1 site in China.
Trial summary
Objective: To establish a study cohort and follow up of patients with CKD in our hospital, and evaluate the status of integrated CKD diagnosis and treatment according to guidelines in the real world, as well as the clinical prognosis of patients with different stratification. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension, Hyperglycemia
- What is being tested?
- Integrated diagnosis and treatment for CKD
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD following up more than 6 months in Beijing Jishuitan Hospital.
Who may be able to join
- ≥18 years old;
- Voluntarily signed informed consent;
- Patients who are estimated to develop CKD.
Who cannot join
- Age < 18 or ≥100 years;
- Unable to comply with the procedures stipulated in this study;
- Estimated follow-up time ≤6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nephrology Department of Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Dongliang Zhang, Director, +860150963534, zhangdongliang@jst-hosp.com.cn
About this study
Official title: A Prospective, Cohort, and Observational Study of the Effect of Integrated Diagnosis and Treatment of Chronic Kidney Disease (CKD) on Clinical Outcomes in Real World Clinical Practice
Objective: To establish a study cohort and follow up of patients with CKD in our hospital, and evaluate the status of integrated CKD diagnosis and treatment according to guidelines in the real world, as well as the clinical prognosis of patients with different stratification.
Methods: By establishing a cohort of 1000 patients with CKD and conducting long-term follow-up, integrated diagnosis and treatment for CKD was performed, namely: Regular monitoring, control of blood pressure, blood glucose, blood lipid, correction of anemia, minerals - bone metabolic abnormalities, malnutrition, acid and alkali, and electrolyte disorder, diet and exercise, such as the guidance of integrated management, non intrusive, observational studies, prospective cohort were analyzed retrospectively, describe the implementation of the integration of diagnosis and treatment, chronic kidney disease (CKD) Stratified analysis and risk factor analysis were performed for cardiovascular disease and other main endpoint events, so as to objectively reflect the status of integrated treatment of CKD and provide data support for continuous quality improvement of CKD diagnosis and treatment and improvement of clinical prognosis of patients.
- Conditions
- Chronic Kidney Diseases, Hypertension, Hyperglycemia, Hyperlipidemias, Anemia, Chronic Kidney Disease-Mineral and Bone Disorder
- Being tested
- Integrated diagnosis and treatment for CKD
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Hyperglycemia, Hyperlipidemias, Anemia, Chronic Kidney Disease-Mineral and Bone Disorder, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated diagnosis and treatment for CKDOther
This is an observational study. Investor will not intervene the clinical practice of doctors. In the real world, there would be many factors affect the proceeding of the guidelines contents. There will be integrated diagnosis and treatment during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Integrated group | Patients in the integrated group should be the patients getting integrated diagnosis and treatment during following up period. Integrated diagnosis and treatment includes control of hypertension, hyperglycemia, hyperlipidemia, anemia, CKD-MBD, and malnutrition by regular follow-up according to the guidelines of Kidney Disease- Improving Global Outcomes and of Chinese Medical Association in 2021. Receives: Other: Integrated diagnosis and treatment for CKD | |
| Unintegrated group | Patients in the unintegrated group are those who do not follow the contents of guidelines in some items of the integrated diagnosis and treatment during follow-up. Receives: Other: Integrated diagnosis and treatment for CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cardiovascular cerebrovascular adverse events
Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up
Measured: Six months or more
Secondary outcomes (1)
Rate of all-cause mortality
Deaths from all causes during follow-up
Measured: Six months or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongliang Zhang, MD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242055
- Sponsor's protocol ID
- 202112-11
- Status last verified
- May 2022
- First submitted
- 29 Jan 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Cohort, and Observational Study of the Effect of Integrated Diagnosis and Treatment of Chronic Kidney Disease (CKD) on Clinical Outcomes in Real World Clinical Practice
- ClinicalTrials.gov ID
- NCT05242055
- Acronym / sponsor ID
- 202112-11
- Conditions
- Chronic Kidney Diseases, Hypertension, Hyperglycemia, Hyperlipidemias, Anemia, Chronic Kidney Disease-Mineral and Bone Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Feb 2022 (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.
Objective: To establish a study cohort and follow up of patients with CKD in our hospital, and evaluate the status of integrated CKD diagnosis and treatment according to guidelines in the real world, as well as the clinical prognosis of patients with different stratification.
Methods: By establishing a cohort of 1000 patients with CKD and conducting long-term follow-up, integrated diagnosis and treatment for CKD was performed, namely: Regular monitoring, control of blood pressure, blood glucose, blood lipid, correction of anemia, minerals - bone metabolic abnormalities, malnutrition, acid and alkali, and electrolyte disorder, diet and exercise, such as the guidance of integrated management, non intrusive, observational studies, prospective cohort were analyzed retrospectively, describe the implementation of the integration of diagnosis and treatment, chronic kidney disease (CKD) Stratified analysis and risk factor analysis were performed for cardiovascular disease and other main endpoint events, so as to objectively reflect the status of integrated treatment of CKD and provide data support for continuous quality improvement of CKD diagnosis and treatment and improvement of clinical prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated group | – | Other: Integrated diagnosis and treatment for CKDPatients in the integrated group should be the patients getting integrated diagnosis and treatment during following up period. Integrated diagnosis and treatment includes control of hypertension, hyperglycemia, hyperlipidemia, anemia, CKD-MBD, and malnutrition by regular follow-up according to the guidelines of Kidney Disease- Improving Global Outcomes and of Chinese Medical Association in 2021. |
| Unintegrated group | – | Other: Integrated diagnosis and treatment for CKDPatients in the unintegrated group are those who do not follow the contents of guidelines in some items of the integrated diagnosis and treatment during follow-up. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD following up more than 6 months in Beijing Jishuitan Hospital.
Key inclusion criteria (3 listed)
- ≥18 years old;
- Voluntarily signed informed consent;
- Patients who are estimated to develop CKD.
Key exclusion criteria (3 listed)
- Age < 18 or ≥100 years;
- Unable to comply with the procedures stipulated in this study;
- Estimated follow-up time ≤6 months.
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 |
|---|---|---|
| Integrated diagnosis and treatment for CKDThis is an observational study. Investor will not intervene the clinical practice of doctors. In the real world, there would be many factors affect the proceeding of the guidelines contents. There will be integrated diagnosis and treatment during follow-up. | Other | Integrated group, Unintegrated group |
Primary outcome
Rate of cardiovascular cerebrovascular adverse events
Time frame: Six months or more
Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up
1 secondary outcome
Rate of all-cause mortality
Time frame: Six months or more
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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.
Nephrology Department of Beijing Jishuitan Hospital
Beijing, China
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 Diseases and Hypertension, run by Capital Medical University 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 3 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: looking for participants now, as of the sponsor's last update on 6 May 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cardiovascular cerebrovascular adverse events (time frame: Six months or more). 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 6 May 2022.