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

NCT05656963 | Unknown

• 1 other identifier: YXLL-KY-2022(102)
• Study Type: observational
• Target: 741
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glomerulonephritis, Membranous; Diabetic Nephropathies; Thrombelastography; Thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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;

  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).

  2021-2024

Study Arms (3)

Idiopathic membranous nephropathy

Patients with idiopathic membranous nephropathy proved by renal biopsy

Other: Grouping based on previous laboratory results, no intervention.

Non-Idiopathic membranous nephropathy

Other primary glomerular diseases except membranous nephropathy

Other: Grouping based on previous laboratory results, no intervention.

Diabetic kidney disease

Patients with clinical diagnosis of diabetes and kidney disease

Other: Grouping based on previous laboratory results, no intervention.

Interventions

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.

Diabetic kidney disease; Idiopathic membranous nephropathy; Non-Idiopathic membranous nephropathy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yipeng Liu: lead

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Diabetic Nephropathies; Thromboembolism

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yipeng Liu

  Qianfoshan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 20, 2022
• Study Start: September 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: January 31, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)