CKDLPACKD45NCT07141628
Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease
An observational study of CKD and Cardiovascular Diseases, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level >125 nmol/L. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CKD, Cardiovascular Diseases
- What is being tested?
- lipoprotein A level dosing
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage 4 chronic kidney disease without replacement therapy followed as outpatients at Nîmes University Hospital.
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient being followed at the Nîmes University Hospital for stage 4 chronic kidney disease without replacement therapy
- Patient available for follow-up at 18 months
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Familial hypercholesterolemia
- Morbid obesity (BMI > 40 kg/m2).
- Persons deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care, and persons admitted to a health or social care facility for purposes other than research (Article L1121-6 of the French Public Health Code)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Olivier Moranne, MD, PhD
About this study
Official title: Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4
The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level >125 nmol/L. Patients with severe chronic kidney disease (CKD) or on hemodialysis are at high cardiovascular risk, and Lp(a) levels would allow for better reclassification of this cardiovascular risk in the general population.
The study authors wished to the heterogeneity of the Lp(a) level in the population with CKD stages 4 without renal replacement therapy and to identify whether a high Lp(a) level is associated with cardiovascular comorbidity defined by the presence of cardiovascular comorbidity after adjustment for known risk factors such as diabetic status, obesity, smoking, LDLc level and medical treatment for cardiovascular prevention (statins, etc.). Furthermore, they will evaluate whether there is a link between a high level (> 125 mmol/l) of Lp(a) at inclusion in the cohort and the occurrence of cardiovascular or renal events (i.e. death of cardiovascular origin or occurrence of MI, stroke, stage 4 peripheral artery disease (PAD) or initiation of renal replacement) over a follow-up period of 18 months which could raise questions about the benefit of a specific treatment which remains to be evaluated.
- Conditions
- CKD, Cardiovascular Diseases
- Being tested
- lipoprotein A level dosing
- Keywords
- lipoproteinA
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipoprotein A level dosingDiagnostic test
Plasma levels measured in mmol/l
| Study group | Role | What they receive |
|---|---|---|
| Patients with stage 4 chronic kidney disease without replacement therapy | Not described Receives: Diagnostic Test: lipoprotein A level dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Link between hyperlipoproteinemia A and a first event of cardiovascular death
cardiovascular death: yes/no
Measured: 18 months
Link between hyperlipoproteinemia A and a first event of myocardial infarction
myocardial infarction: yes/no
Measured: 18 months
Link between hyperlipoproteinemia A and a first event of stroke
stroke: yes/no
Measured: 18 months
Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4
peripheral artery disease stage 4: yes/no
Measured: 18 months
Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy
initiation of renal replacement therapy: yes/no
Measured: 18 months
Secondary outcomes (9)
Rate of hyperlipoproteinemia A
defined as a lipoprotein A level > 125 nmol/L
Measured: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion
Ischemic heart disease: yes/no
Measured: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion
Ischemic stroke: yes/no
Measured: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion
Calcified aortic stenosis: yes/no
Measured: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion
Lower limb arterial disease stage 2-4: yes/no
Measured: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion
Vascular nephropathy: yes/no
Measured: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion
coronary artery or limb angioplasty: yes/no
Measured: Month 18
Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up
hospitalization for cardiac decompensation: yes/no
Measured: Month 18
Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up
Cumulative events from the following: myocardial infarction, stroke, PAD stage 4, initiation of renal replacement therapy, death, arterial angioplasty at any site, cardiac decompensation
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jul 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Moranne, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141628
- Sponsor's protocol ID
- NIMAO/2024-2/OM01
- Acronym
- LPACKD45
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4
- ClinicalTrials.gov ID
- NCT07141628
- Acronym / sponsor ID
- LPACKD45 / NIMAO/2024-2/OM01
- Conditions
- CKD, Cardiovascular Diseases
- Keywords
- lipoproteinA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Aug 2025 (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.
The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level >125 nmol/L. Patients with severe chronic kidney disease (CKD) or on hemodialysis are at high cardiovascular risk, and Lp(a) levels would allow for better reclassification of this cardiovascular risk in the general population.
The study authors wished to the heterogeneity of the Lp(a) level in the population with CKD stages 4 without renal replacement therapy and to identify whether a high Lp(a) level is associated with cardiovascular comorbidity defined by the presence of cardiovascular comorbidity after adjustment for known risk factors such as diabetic status, obesity, smoking, LDLc level and medical treatment for cardiovascular prevention (statins, etc.). Furthermore, they will evaluate whether there is a link between a high level (> 125 mmol/l) of Lp(a) at inclusion in the cohort and the occurrence of cardiovascular or renal events (i.e. death of cardiovascular origin or occurrence of MI, stroke, stage 4 peripheral artery disease (PAD) or initiation of renal replacement) over a follow-up period of 18 months which could raise questions about the benefit of a specific treatment which remains to be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stage 4 chronic kidney disease without replacement therapy | – | Diagnostic Test: lipoprotein A level dosing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage 4 chronic kidney disease without replacement therapy followed as outpatients at Nîmes University Hospital.
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient being followed at the Nîmes University Hospital for stage 4 chronic kidney disease without replacement therapy
- Patient available for follow-up at 18 months
Key exclusion criteria (7 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Familial hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipoprotein A level dosingPlasma levels measured in mmol/l | Diagnostic test | Patients with stage 4 chronic kidney disease without replacement therapy |
Primary outcome
Link between hyperlipoproteinemia A and a first event of cardiovascular death
Time frame: 18 months
cardiovascular death: yes/no
Link between hyperlipoproteinemia A and a first event of myocardial infarction
Time frame: 18 months
myocardial infarction: yes/no
Link between hyperlipoproteinemia A and a first event of stroke
Time frame: 18 months
stroke: yes/no
Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4
Time frame: 18 months
peripheral artery disease stage 4: yes/no
Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy
Time frame: 18 months
initiation of renal replacement therapy: yes/no
9 secondary outcomes
Rate of hyperlipoproteinemia A
Time frame: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion
Time frame: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion
Time frame: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion
Time frame: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion
Time frame: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion
Time frame: Baseline (Day 0)
Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion
Time frame: Month 18
Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up
Time frame: Month 18
Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up
Time frame: Month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
Olivier Moranne principal investigator
Centre Hospitalier Universitaire de Nīmes
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 CKD and Cardiovascular Diseases, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Moranne (04.66.68.32.59, olivier.moranne@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Link between hyperlipoproteinemia A and a first event of cardiovascular death (time frame: 18 months). The study lists 5 primary outcomes in all. 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 20 Oct 2026.