Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

• Conditions: Nephrotic Syndrome

• Registration Number: NCT05301829
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The thromboembolic risk is increased during the nephrotic syndrome (NS) with an incidence of deep vein thrombosis 15%, pulmonary embolism of 10-30% and renal vein thrombosis of 25-37%. There is a hemostatic imbalance with urinary leakage of anticoagulant factors and increased hepatic synthesis of procoagulant factors, platelet hyperaggregability and a decrease in fibrinolytic activity. However, the identification of patients requiring anticoagulant prophylaxis remains imprecise.The thromboembolic risk is higher when the NS is related to extramembranous glomerulonephritis comparatively to others glomerulopathies. The reason of this difference is not still known. This risk increase with SN's severity and therefore with the decrease of albuminemia. Moreover, few studies have evaluated anticoagulant treatment efficacy during a NS, which clinical benefit depends also on hemorrhagic risk specific of each patient. Thus, the determination of the thrombotic risk and the modalities of anticoagulation are variable and perfectible during the NS.

We propose to use the thrombin generation test (TGT) to quantify the thromboembolic risk in patients with a NS and to follow its evolution during prophylactic anticoagulation and after remission of NS.

Detailed Description

Thrombin generation test will be performed prospectively in nephrotic patients with various diseases (Minimal Change Disease (MCD), Malignant Nephrosclerosis (MN), Focal Segmental GlomeruloSclerosis (FSGS), diabetic glomerulopathy...) at diagnosis, during anticoagulant treatment (D8±3) and after disease remission (M6).

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Study Start: 2022-04-01
• Primary Completion: 2022-10-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Nephrotic syndrome
• Known cause of nephrotic syndrome (renal biopsy and/or positive anti-PLA2R)

Exclusion Criteria

• Active anticoagulation treatment before TGT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.	6 months	Number of thrombotic events at 6 months of follow-up

Secondary Outcome Measures

Name	Time	Method
Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up	Maximum 6 months (when albumin > 30 g/l)	To calculate the difference of TGT parameters between the time of acute phase of NS (at diagnosis = inclusion), and after NS remission.
Compare the theoric indications for anticoagulation therapy according to TGT parameters with those of the Lin R algorithm and "Kidney Disease: Improving Global Outcomes" (KDIGO) 2021	At diagnosis = at inclusion	Percentage of anticoagulated patients versus theoric number, based on TGT results and available algorithms

Trial Locations

Locations (1)

Service de Néphrologie et Dialyses, Hôpital Tenon; 🇫🇷 Paris, France