Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

Nephrotic Syndrome Clinical Trial

— TGANephrotic  

Official title:

Thrombin Generation Assay to Assess Thrombotic Risk and the Evolution of the Hypercoagulability Profile of Patients With Nephrotic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05301829
• Other study ID #: APHP220213
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Armance MARCHAL, MD
• Phone: 1 56 01 60 43
• Email: armance.marchal[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: March 31, 2024
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Nephrotic syndrome

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

Exclusion Criteria:

• Active anticoagulation treatment before TGT

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Service de Néphrologie et Dialyses, Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.	Number of thrombotic events at 6 months of follow-up	6 months
Secondary	Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up	To calculate the difference of TGT parameters between the time of acute phase of NS (at diagnosis = inclusion), and after NS remission.	Maximum 6 months (when albumin > 30 g/l)
Secondary	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	Percentage of anticoagulated patients versus theoric number, based on TGT results and available algorithms	At diagnosis = at inclusion