The Influencing Factors and Mechanism of High Incidence of Thrombotic Events in Patients With MN and DKD

Thromboembolism Clinical Trial

Official title:

Influence Factors and Preliminary Mechanism of High Incidence of Thrombotic Events in Patients With Idiopathic Membranous Nephropathy and Diabetes Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05656963
• Other study ID #: YXLL-KY-2022(102)
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Influence factors and preliminary mechanism of high incidence of thrombotic events in patients with idiopathic membranous nephropathy and diabetes kidney disease

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 741
• Est. completion date: January 31, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Primary glomerular disease patients with renal biopsy results (without hormone or immunosuppressive therapy) and patients with clinical diagnosis of diabetes kidney disease;

2. Age 18-70;

3. The liver function is normal.

Exclusion Criteria:

1. Other secondary kidney diseases except diabetes; Acute renal injury; Chronic kidney disease stage 5;

2. There are risk factors of hypercoagulability, such as acute infection, recent trauma, surgery or cancer, pregnancy;

3. Anticoagulant and antiplatelet drugs were given within one week;

4. Plasma infusion, plasma exchange or hemodialysis within one month;

5. There is a history of thrombotic disease or hemorrhagic disease before renal puncture;

6. Participated in other clinical studies within three months.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Glomerulonephritis
• Glomerulonephritis, Membranous
• Kidney Diseases
• Thrombelastography
• Thromboembolism

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yipeng Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. ? 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); ? 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; ? 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;	2021-2024
Primary	Specific link between high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy	? 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); ? 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).	2021-2024