NCT07390604

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 14, 2026

Last Update Submit

February 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    up to 15 months after inclusion

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

    up to 15 months after inclusion

  • cardiovascular or thromboembolic events

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

  • Hemodynamic status:blood pressure

    up to 15 months after inclusion

  • Hemodynamic status: ultrafiltration rate

    up to 15 months after inclusion

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic Hemodialsisi patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zead TUBAIL, MD

    CHR Metz-Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

February 5, 2026

Study Start

July 1, 2025

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations