Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease

Study acronym: LPACKD45
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 2027 → Jan 1, 2028
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Jan 2026 to Jul 1, 2026
    • Primary and study completion pushed from Sep 2027 to Jan 1, 2028
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 8 of 9 entries
    • Site details revised
  2. Notable Start date: Sep 2025 to Jan 2026v2 Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study title revised
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07141628
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions
(from sponsor)
CKD, Cardiovascular Diseases
Related terms Cardiovascular Diseases
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov