Glomerulonephritis, MembranousNCT05656963
The Influencing Factors and Mechanism of High Incidence of Thrombotic Events in Patients With MN and DKD
An observational study of Glomerulonephritis, Membranous and Diabetic Nephropathies, run by Yipeng Liu at 1 site in China.
Trial summary
Influence factors and preliminary mechanism of high incidence of thrombotic events in patients with idiopathic membranous nephropathy and diabetes kidney disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glomerulonephritis, Membranous, Diabetic Nephropathies, Thrombelastography
- How many people
- 741 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were diagnosed as primary glomerular disease by renal puncture biopsy and diabetes renal disease by clinical diagnosis and underwent thromboelastography (TEG) examination at the same time were newly treated patients and were not treated with hormone and other immunosuppressants.
Who may be able to join
- Primary glomerular disease patients with renal biopsy results (without hormone or immunosuppressive therapy) and patients with clinical diagnosis of diabetes kidney disease;
- Age 18-70;
- The liver function is normal.
Who cannot join
- Other secondary kidney diseases except diabetes; Acute renal injury; Chronic kidney disease stage 5;
- There are risk factors of hypercoagulability, such as acute infection, recent trauma, surgery or cancer, pregnancy;
- Anticoagulant and antiplatelet drugs were given within one week;
- Plasma infusion, plasma exchange or hemodialysis within one month;
- There is a history of thrombotic disease or hemorrhagic disease before renal puncture;
- Participated in other clinical studies within three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence Factors and Preliminary Mechanism of High Incidence of Thrombotic Events in Patients With Idiopathic Membranous Nephropathy and Diabetes Kidney Disease
Influence factors and preliminary mechanism of high incidence of thrombotic events in patients with idiopathic membranous nephropathy and diabetes kidney disease
Read the detailed description
According to the results of renal biopsy, the patients were divided into three groups: membranous nephropathy group (MN), non-membranous nephropathy group (non-MN) and diabetes kidney disease group (DKD). Collect the basic data and TEG test results of the enrolled patients. (1) ① According to TEG results, the enrolled patients were divided into two groups: hypercoagulable group (CI > 3) and non-hypercoagulable group (CI ≤ 3). The basic data and related laboratory indicators of the two groups were compared - to explore the influencing factors of hypercoagulable (objective X); ② Compare the parameters related to TEG and coagulation routine between MN group and non-MN group, DKD group and non-MN group respectively - find out the coagulation index (target Y) of the difference between groups; ③ Build regression models for different target Y - explore the influencing factors of grouping variables (MN vs non MN or DKD vs non MN) on Y after adjusting other covariates; (2) ① According to whether the patients in the group had thrombotic events or not, all the patients in the group with thrombotic events were divided into MN thrombotic events group and non-MN thrombotic events group according to pathological diagnosis, and the TEG, coagulation and other related laboratory results and basic data between the two groups were compared (explore the unique factors and processes that affect the occurrence of thrombotic events in MN group compared with non-MN group); ② According to whether the patients in the MN group who were hospitalized for many times had thrombotic events, the patients were divided into the MN group with thrombotic events and the MN group without thrombotic events. The TEG, coagulation and other related laboratory results and basic data between the two groups were compared (to explore the factors and processes that affect the occurrence of thrombotic events in the MN group).
- Conditions
- Glomerulonephritis, Membranous, Diabetic Nephropathies, Thrombelastography, Thromboembolism
- Being tested
- Grouping based on previous laboratory results, no intervention.
- Medical subject headings
- Glomerulonephritis, Membranous, Diabetic Nephropathies, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grouping based on previous laboratory results, no intervention.Other
The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic membranous nephropathy | Patients with idiopathic membranous nephropathy proved by renal biopsy Receives: Other: Grouping based on previous laboratory results, no intervention. | |
| Non-Idiopathic membranous nephropathy | Other primary glomerular diseases except membranous nephropathy Receives: Other: Grouping based on previous laboratory results, no intervention. | |
| Diabetic kidney disease | Patients with clinical diagnosis of diabetes and kidney disease Receives: Other: Grouping based on previous laboratory results, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors influencing the high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy
Collect the basic data of the enrolled patients, including admission blood pressure, smoking, drinking history, the use of statins, anticoagulants and antiplatelet drugs, and blood test indicator. All indicators for inclusion in the analysis are presented in full by subgroup. ① the enrolled patients were divided into two groups according to TEG results: hypercoagulable group (CI > 3) vs non hypercoagulable group (CI ≤ 3). The basic data and related laboratory parameters of the two groups were compared to explore the influence of hypercoagulability factors (AIM X); ② Comparison of TEG and coagulation routine related parameters between MN and non MN group, DKD and non MN group - to find the coagulation indexes (target Y) that differ in TEG and coagulation routine between groups; ③ Regression models were constructed separately for different targets Y - to explore the influence of grouping variables (MN vs non MN or DKD vs non MN) on y after adjusting for other covariates;
Measured: 2021-2024
Specific link between high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy
① Based on collecting whether all the patients enrolled in multiple hospitalizations had thrombotic events, all the patients enrolled with thrombotic events were divided into MN with thrombotic events group and non MN with thrombotic events group according to the pathological diagnosis, and relevant assay results such as TEG, coagulation and basic data were compared between the two groups (to explore the specific factors and processes influencing the occurrence of thrombotic events specifically in the MN group compared to the non MN group); ② Based on whether thrombotic events occurred in patients within the Mn group enrolled in multiple hospitalizations, patients were divided into Mn with thrombotic events and Mn without thrombotic events groups, and relevant laboratory results and basic data such as TEG and coagulation were compared between the two groups (to explore factors and processes influencing the occurrence of thrombotic events in patients within the MN group).
Measured: 2021-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Sep 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 741 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yipeng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yipeng Liu, Qianfoshan Hospital
- Investigators
- Yipeng Liu, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656963
- Sponsor's protocol ID
- YXLL-KY-2022(102)
- Status last verified
- Jul 2023
- First submitted
- 24 Nov 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Factors and Preliminary Mechanism of High Incidence of Thrombotic Events in Patients With Idiopathic Membranous Nephropathy and Diabetes Kidney Disease
- ClinicalTrials.gov ID
- NCT05656963
- Acronym / sponsor ID
- YXLL-KY-2022(102)
- Conditions
- Glomerulonephritis, Membranous, Diabetic Nephropathies, Thrombelastography, Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 741 participants (estimated)
- Lead sponsor
- Yipeng LiuUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 20 Dec 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.
Influence factors and preliminary mechanism of high incidence of thrombotic events in patients with idiopathic membranous nephropathy and diabetes kidney disease
Detailed description
According to the results of renal biopsy, the patients were divided into three groups: membranous nephropathy group (MN), non-membranous nephropathy group (non-MN) and diabetes kidney disease group (DKD). Collect the basic data and TEG test results of the enrolled patients. (1) ① According to TEG results, the enrolled patients were divided into two groups: hypercoagulable group (CI > 3) and non-hypercoagulable group (CI ≤ 3). The basic data and related laboratory indicators of the two groups were compared - to explore the influencing factors of hypercoagulable (objective X); ② Compare the parameters related to TEG and coagulation routine between MN group and non-MN group, DKD group and non-MN group respectively - find out the coagulation index (target Y) of the difference between groups; ③ Build regression models for different target Y - explore the influencing factors of grouping variables (MN vs non MN or DKD vs non MN) on Y after adjusting other covariates; (2) ① According to whether the patients in the group had thrombotic events or not, all the patients in the group with thrombotic events were divided into MN thrombotic events group and non-MN thrombotic events group according to pathological diagnosis, and the TEG, coagulation and other related laboratory results and basic data between the two groups were compared (explore the unique factors and processes that affect the occurrence of thrombotic events in MN group compared with non-MN group); ② According to whether the patients in the MN group who were hospitalized for many times had thrombotic events, the patients were divided into the MN group with thrombotic events and the MN group without thrombotic events. The TEG, coagulation and other related laboratory results and basic data between the two groups were compared (to explore the factors and processes that affect the occurrence of thrombotic events in the MN group).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Idiopathic membranous nephropathy | – | Other: Grouping based on previous laboratory results, no intervention.Patients with idiopathic membranous nephropathy proved by renal biopsy |
| Non-Idiopathic membranous nephropathy | – | Other: Grouping based on previous laboratory results, no intervention.Other primary glomerular diseases except membranous nephropathy |
| Diabetic kidney disease | – | Other: Grouping based on previous laboratory results, no intervention.Patients with clinical diagnosis of diabetes and kidney disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were diagnosed as primary glomerular disease by renal puncture biopsy and diabetes renal disease by clinical diagnosis and underwent thromboelastography (TEG) examination at the same time were newly treated patients and were not treated with hormone and other immunosuppressants.
Key inclusion criteria (3 listed)
- Primary glomerular disease patients with renal biopsy results (without hormone or immunosuppressive therapy) and patients with clinical diagnosis of diabetes kidney disease;
- Age 18-70;
- The liver function is normal.
Key exclusion criteria (6 listed)
- Other secondary kidney diseases except diabetes; Acute renal injury; Chronic kidney disease stage 5;
- There are risk factors of hypercoagulability, such as acute infection, recent trauma, surgery or cancer, pregnancy;
- Anticoagulant and antiplatelet drugs were given within one week;
- Plasma infusion, plasma exchange or hemodialysis within one month;
- There is a history of thrombotic disease or hemorrhagic disease before renal puncture;
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 |
|---|---|---|
| Grouping based on previous laboratory results, no intervention.The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken. | Other | Diabetic kidney disease, Idiopathic membranous nephropathy, Non-Idiopathic membranous nephropathy |
Primary outcome
Factors influencing the high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy
Time frame: 2021-2024
Collect the basic data of the enrolled patients, including admission blood pressure, smoking, drinking history, the use of statins, anticoagulants and antiplatelet drugs, and blood test indicator. All indicators for inclusion in the analysis are presented in full by subgroup. ① the enrolled patients were divided into two groups according to TEG results: hypercoagulable group (CI > 3) vs non hypercoagulable group (CI ≤ 3). The basic data and related laboratory parameters of the two groups were compared to explore the influence of hypercoagulability factors (AIM X); ② Comparison of TEG and coagulation routine related parameters between MN and non MN group, DKD and non MN group - to find the coagulation indexes (target Y) that differ in TEG and coagulation routine between groups; ③ Regression models were constructed separately for different targets Y - to explore the influence of grouping variables (MN vs non MN or DKD vs non MN) on y after adjusting for other covariates;
Specific link between high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy
Time frame: 2021-2024
① Based on collecting whether all the patients enrolled in multiple hospitalizations had thrombotic events, all the patients enrolled with thrombotic events were divided into MN with thrombotic events group and non MN with thrombotic events group according to the pathological diagnosis, and relevant assay results such as TEG, coagulation and basic data were compared between the two groups (to explore the specific factors and processes influencing the occurrence of thrombotic events specifically in the MN group compared to the non MN group); ② Based on whether thrombotic events occurred in patients within the Mn group enrolled in multiple hospitalizations, patients were divided into Mn with thrombotic events and Mn without thrombotic events groups, and relevant laboratory results and basic data such as TEG and coagulation were compared between the two groups (to explore factors and processes influencing the occurrence of thrombotic events in patients within the MN group).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Yipeng Liu study chair
Qianfoshan 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 Glomerulonephritis, Membranous and Diabetic Nephropathies, run by Yipeng Liu 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. 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?
Factors influencing the high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy (time frame: 2021-2024). 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 18 Jul 2023.