Alirocumab in Patients on a Stable Dialysis Regimen
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBaylor Research Institute
About this trial
12-week study of the efficacy and safety of alirocumab in patients maintained stably on hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9 levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients, ages 18 to 80 years.
Written informed consent will be obtained before any study assessment is performed.
Diagnosis of end-stage renal disease, maintained on dialysis, without dialysis complications, for at least 3 months.
Patients may or may not have a diagnosis of atherosclerotic disease, such as a history of myocardial infarction (MI), cardiac percutaneous coronary intervention (PCI), coronary artery bypass (CABG) surgery, atherosclerotic transient ischemic attack (TIA) or cerebrovascular attack (CVA), or peripheral arterial disease (PAD).
Disqualifiers
LDL-cholesterol level of < 70 mg/dL.
Any contraindication to subcutaneous injections.
Patients on statin and/or ezetimibe therapy will have their cholesterol-lowering therapy continued as is without change during the time of the study.
History of any allergy or intolerance to the study drug or drugs of the same class.
Trial design
Design model
Single group
Treatments tested in this trial
Alirocumab 150 MG/ML [Praluent]
DrugCholesterol-lowering therapy
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: alirocumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in LDL cholesterol levels
Efficacy
Time frame
Baseline, 4 ,8, 12 weeksSecondary outcomes
1
Change in HDL-cholesterol levels
Efficacy
Time frame
Baseline, 12 weeks2
Change in apoprotein B levels
Efficacy
Time frame
Baseline, 4, 8, 12 weeksOther outcomes
1
Change in PCSK9 levels
Efficacy
Time frame
Baseline, 4, 8, 10, 12 weeks2
Change in alirocumab drug levels
Efficacy
Time frame
Baseline, 4, 8, 10, 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor Research Institute
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov