Lipoprotein(a)LiPo-ANCT07390604
Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease ; ( LiPo-A )
An observational study of Lipoprotein(a) and Lipoprotein-apheresis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipoprotein(a), Lipoprotein-apheresis, Double-filtration Plasmapheresis
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: chronic Hemodialsisi patients
Who may be able to join
- 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
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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 .
- Conditions
- Lipoprotein(a), Lipoprotein-apheresis, Double-filtration Plasmapheresis, Hemodialysis Complication, End Stage Chronic Renal Failure
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Lp(a) concentration (nmol/L), on routine venous blood sampling
Before and after each DFPP session (repeated measures) during the study period
Measured: up to 15 months after inclusion
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 15 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein(a)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zead TUBAIL, MD, Principal investigator, CHR Metz-Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390604
- Sponsor's protocol ID
- 2025-03Obs-CHRMT
- Acronym
- LiPo-A
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07390604
- Acronym / sponsor ID
- LiPo-A / 2025-03Obs-CHRMT
- Conditions
- Lipoprotein(a), Lipoprotein-apheresis, Double-filtration Plasmapheresis, Hemodialysis Complication, End Stage Chronic Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- chronic Hemodialsisi patients
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
serum LDL and serum triglycerides concentration (g/L), on routine venous blood sampling
Time frame: up to 15 months after inclusion
serum triglycerides concentration (g/L), on routine venous blood sampling
Time frame: up to 15 months after inclusion
cardiovascular or thromboembolic events
Time frame: during all the study period: up to 15 months after inclusion
Hemodynamic status:blood pressure
Time frame: up to 15 months after inclusion
Hemodynamic status: ultrafiltration rate
Time frame: up to 15 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zead TUBAIL, MD principal investigator
CHR Metz-Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoprotein(a) and Lipoprotein-apheresis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum Lp(a) concentration (nmol/L), on routine venous blood sampling (time frame: up to 15 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.