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

July 17, 2023 updated by: Yipeng Liu

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
741

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Qianfoshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Idiopathic membranous nephropathy
Patients with idiopathic membranous nephropathy proved by renal biopsy
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.
Non-Idiopathic membranous nephropathy
Other primary glomerular diseases except membranous nephropathy
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.
Diabetic kidney disease
Patients with clinical diagnosis of diabetes and kidney disease
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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;
2021-2024
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).
2021-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yipeng Liu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yipeng Liu, Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YXLL-KY-2022(102)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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