Chronic Kidney DiseasesNCT05476627
Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases
An observational study of Chronic Kidney Diseases and Hypertension, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension, Diabetes Mellitus
- What is being tested?
- Biomarkers
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2027
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is consecutively enrolled from outpatient and inpatient department of our hospital.
Who may be able to join
- The diagnosis of metabolic diseases were confirmed;
- Be able to understand the process of the research;
- Volunteer for participation and be able to sign the informed consent.
Who cannot join
- Age <18 yrs or >80yrs;
- Patients with primary and secondary glomerular diseases
- Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors;
- Contraindications for MRI examination;
- Pregnant or lactation patients;
- Patients with unstable vital signs, failure of other organs or dysphoria.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan Liu, +86-15811568692, liuyanpumch@163.com
About this study
With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. The pathophysiological mechanism of renal injury caused by metabolic diseases has always been a hotspot of research. Currently, it is believed that various mechanisms including the activation of Renin-Angiotensin-Aldosterone System, vascular endothelial dysfunction, oxidative stress and inflammatory process may be involved. Although there are differences in renal pathological manifestations caused by different metabolic diseases, the kidney will eventually present ischemic changes and fibrosis with the progression of the disease. So there must be some common pathogenesis. This study is designed to build a disease cohort of patients with chronic kidney disease caused by metabolic diseases, to identify risk factors leading to disease progression and to explore biomarkers for early diagnosis and treatment of kidney damage.
- Conditions
- Chronic Kidney Diseases, Hypertension, Diabetes Mellitus, Hyperuricemia, Obesity
- Being tested
- Biomarkers
- Keywords
- chronic kidney disease, metabolic diseases, biomarker, functional imaging techniques
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Diabetes Mellitus, Hyperuricemia, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomarkersDiagnostic test
Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension Group | Not described Receives: Diagnostic Test: Biomarkers | |
| Diabetes Group | Not described Receives: Diagnostic Test: Biomarkers | |
| Hyperuricemia | Not described Receives: Diagnostic Test: Biomarkers | |
| Obesity | Not described Receives: Diagnostic Test: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with End Stage Renal Disease
End Stage Renal Disease
Measured: 3 years
Number of Participants with Adverse cardiovascular events
Adverse cardiovascular events
Measured: 3 years
Number of Participants with all cause death
All cause death
Measured: 3 years
Secondary outcomes (4)
Number of Participants with eGFR decline
the decline of eGFR during follow-up
Measured: 3 years
Number of Participants with Complications of CKD
The complications of CKD
Measured: 3 years
Life quality assessment with short form-36 (SF-36)
The SF-36 is a patient-reported instrument designed to assess overall health status; it is usually utilized to measure patients' quality of life and used primarily in research. Increasing SF-36 scores are indicative of improving health status.
Measured: 3 years
Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE)
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point) . While different cutoff points have been used across studies, scores ≤23 are most commonly regarded as abnormal and indicative of cognitive impairment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2027 (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 Peking Union Medical College 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limeng Chen, Peking Union Medical College Hospital
- Investigators
- Limeng Chen, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476627
- Sponsor's protocol ID
- JS-2136
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-privatized data are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases
- ClinicalTrials.gov ID
- NCT05476627
- Acronym / sponsor ID
- JS-2136
- Conditions
- Chronic Kidney Diseases, Hypertension, Diabetes Mellitus, Hyperuricemia, Obesity
- Keywords
- chronic kidney disease, metabolic diseases, biomarker, functional imaging techniques
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jul 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.
With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. The pathophysiological mechanism of renal injury caused by metabolic diseases has always been a hotspot of research. Currently, it is believed that various mechanisms including the activation of Renin-Angiotensin-Aldosterone System, vascular endothelial dysfunction, oxidative stress and inflammatory process may be involved. Although there are differences in renal pathological manifestations caused by different metabolic diseases, the kidney will eventually present ischemic changes and fibrosis with the progression of the disease. So there must be some common pathogenesis. This study is designed to build a disease cohort of patients with chronic kidney disease caused by metabolic diseases, to identify risk factors leading to disease progression and to explore biomarkers for early diagnosis and treatment of kidney damage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypertension Group | – | Diagnostic Test: Biomarkers |
| Diabetes Group | – | Diagnostic Test: Biomarkers |
| Hyperuricemia | – | Diagnostic Test: Biomarkers |
| Obesity | – | Diagnostic Test: Biomarkers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is consecutively enrolled from outpatient and inpatient department of our hospital.
Key inclusion criteria (3 listed)
- The diagnosis of metabolic diseases were confirmed;
- Be able to understand the process of the research;
- Volunteer for participation and be able to sign the informed consent.
Key exclusion criteria (6 listed)
- Age <18 yrs or >80yrs;
- Patients with primary and secondary glomerular diseases
- Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors;
- Contraindications for MRI examination;
- Pregnant or lactation patients;
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 |
|---|---|---|
| BiomarkersBlood,urine and imaging biomarkers for early diagnosis and prediction of prognosis. | Diagnostic test | Diabetes Group, Hypertension Group, Hyperuricemia, Obesity |
Primary outcome
Number of Participants with End Stage Renal Disease
Time frame: 3 years
End Stage Renal Disease
Number of Participants with Adverse cardiovascular events
Time frame: 3 years
Adverse cardiovascular events
Number of Participants with all cause death
Time frame: 3 years
All cause death
4 secondary outcomes
Number of Participants with eGFR decline
Time frame: 3 years
Number of Participants with Complications of CKD
Time frame: 3 years
Life quality assessment with short form-36 (SF-36)
Time frame: 3 years
Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE)
Time frame: 3 years
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 16 Aug 2022.
- Individual participant dataSharing planned: Undecided. De-privatized data are to be shared with other researchers.
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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.
Limeng Chen principal investigator
Peking Union Medical College Hospital
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 Peking Union Medical College 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 6 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 16 Aug 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?
Contact Yan Liu (+86-15811568692, liuyanpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with End Stage Renal Disease (time frame: 3 years). The study lists 3 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 16 Aug 2022.