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

NCT ID: NCT05656963

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 741 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-01-31

Brief Summary

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).

Conditions

Glomerulonephritis, Membranous; Diabetic Nephropathies; Thrombelastography; Thromboembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Idiopathic membranous nephropathy

Patients with idiopathic membranous nephropathy proved by renal biopsy

Grouping based on previous laboratory results, no intervention.

Intervention Type: OTHER

The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken.

Non-Idiopathic membranous nephropathy

Other primary glomerular diseases except membranous nephropathy

Grouping based on previous laboratory results, no intervention.

Intervention Type: OTHER

The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken.

Diabetic kidney disease

Patients with clinical diagnosis of diabetes and kidney disease

Grouping based on previous laboratory results, no intervention.

Intervention Type: OTHER

The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yipeng Liu

OTHER

Sponsor Role: lead

Responsible Party

Yipeng Liu

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yipeng Liu

Role: STUDY_CHAIR

Qianfoshan Hospital

Locations

Qianfoshan Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

YXLL-KY-2022(102)

Identifier Type: -

Identifier Source: org_study_id