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Completed

NCT Number: NCT07390604

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

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.

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Key information

Conditions

Lipoprotein(a) Chronic Disease Disease Attributes Double-Filtration Plasmapheresis End Stage Chronic Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Complication Kidney Diseases Lipoprotein-apheresis Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville Hopital de Mercy

Metz, 57085, France

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. serum Lp(a) concentration (nmol/L), on routine venous blood sampling

    Time frame: up to 15 months after inclusion

    Before and after each DFPP session (repeated measures) during the study period

Secondary outcomes

  1. serum LDL and serum triglycerides concentration (g/L), on routine venous blood sampling

    Time frame: up to 15 months after inclusion

    before and after each DFPP session (repeated measures) during the study period

  2. serum triglycerides concentration (g/L), on routine venous blood sampling

    Time frame: up to 15 months after inclusion

    before and after each DFPP session (repeated measures) during the study period

  3. cardiovascular or thromboembolic events

    Time frame: during all the study period: up to 15 months after inclusion

    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

  4. Hemodynamic status:blood pressure

    Time frame: up to 15 months after inclusion

    follow-up of patients' blood pressure (mmHg) before and after each DFPP session (repeated measures) during the study period

  5. Hemodynamic status: ultrafiltration rate

    Time frame: up to 15 months after inclusion

    follow-up of patients' ultrafiltration rate (grams) before and after each DFPP session (repeated measures) during the study period

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: LiPo-A

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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