Clinical trial NCT05656963: The Influencing Factors and Mechanism of High Incidence of Thrombotic Events in Patients With MN and DKD
Official title: Influence Factors and Preliminary Mechanism of High Incidence of Thrombotic Events in Patients With Idiopathic Membranous Nephropathy and Diabetes Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glomerulonephritis, Membranous
Diabetic Nephropathies
Thrombelastography
Thromboembolism
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 741
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

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.

Primary outcomes:
measure: Factors influencing the high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy
timeFrame: 2021-2024
measure: Specific link between high incidence of thrombotic events in patients with membranous nephropathy and diabetic nephropathy
timeFrame: 2021-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Yipeng Liu
role: STUDY_CHAIR
References: