Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease ; ( LiPo-A ) (LiPo-A)

Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease Clinical and Biological Outcomes in Patients at Cardiovascular and Thromboembolic Risk

Lipoprotein-apheresis DFPP has been performed in patients with Lp(a) levels greater than 125 nmol/L. In this report, data will be presented on five hemodialysis patients with significantly elevated Lp(a) levels (>200 nmol/L) who had a history of cardiovascular disease and notable thromboembolic events.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Lipoprotein(a); End Stage Chronic Renal Failure; Lipoprotein-apheresis; Double-filtration Plasmapheresis

Detailed Description

The biological and clinical outcomes related to Lipoprotein-apheresis DFPP treatment and the associated cardiovascular and thromboembolic events will be described in these patients. Additionally, the impact of DFPP on biological and clinical markers including LDL cholesterol, triglycerides, fibrinogen, hemoglobin, platelet count, C-reactive protein (CRP), blood pressure, plasma volume treated, volume of albumin substitution, volume of plasma rejected, and duration of each Lipoprotein-apheresis DFPP session will be evaluated .

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

chronic Hemodialsisi patients

Description

Inclusion Criteria:

• Chronic hemodialysis patients with elevated Lp(a) levels (>200 nmol/L) and a history of cardiovascular disease and/or thromboembolic events who underwent DFPP sessions as part of their management

Exclusion Criteria:

• -Patients with progressive, active disease, presenting with severe general deterioration and a limited life expectancy
• Patients presenting with hemodynamic instability
• Patients presenting with acute kidney diseases.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum Lp(a) concentration (nmol/L), on routine venous blood sampling	Before and after each DFPP session (repeated measures) during the study period	up to 15 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum LDL and serum triglycerides concentration (g/L), on routine venous blood sampling	before and after each DFPP session (repeated measures) during the study period	up to 15 months after inclusion
serum triglycerides concentration (g/L), on routine venous blood sampling	before and after each DFPP session (repeated measures) during the study period	up to 15 months after inclusion
cardiovascular or thromboembolic events	Myocardial infarction, stroke, Deep vein thrombosis, Pulmonary embolism, Systemic arterial embolism, aortiques complictions, thrombosis, Based on patient questioning and clinical examination during routine follow-up consultations	during all the study period: up to 15 months after inclusion
Hemodynamic status:blood pressure	follow-up of patients' blood pressure (mmHg) before and after each DFPP session (repeated measures) during the study period	up to 15 months after inclusion
Hemodynamic status: ultrafiltration rate	follow-up of patients' ultrafiltration rate (grams) before and after each DFPP session (repeated measures) during the study period	up to 15 months after inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Zead TUBAIL, MD, CHR Metz-Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2025-03Obs-CHRMT

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