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New treatment option for Hemodialysis
Official title Alirocumab in Patients on a Stable Dialysis Regimen
ClinicalTrials.gov ID: NCT03480568
What this study is testing
What is Alirocumab 150 MG/ML [Praluent]?
Alirocumab 150 MG/ML [Praluent] is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hemodialysis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- A total of 20 patients will be enrolled, 10 patients on hemodialysis and 10 patients on peritoneal dialysis.
You likely can't join if
- 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.
- A history of MI, PCI, CABG surgery, TIA, CVA, or PAD events within 3 months of enrollment.
- History of malignant cancer within the past 3 years, excepting basal cell skin cancer or cervical cancer in situ.
See the full eligibility criteria
- 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...
- A total of 20 patients will be enrolled, 10 patients on hemodialysis and 10 patients on peritoneal dialysis.
- 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.
- A history of MI, PCI, CABG surgery, TIA, CVA, or PAD events within 3 months of enrollment.
- History of malignant cancer within the past 3 years, excepting basal cell skin cancer or cervical cancer in situ.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of the drug and for 2 weeks after the...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive...
- Male sterilization (at least 6 months prior to enrollment). For female patients in the study, the vasectomized male partner should be the sole partner for that patient.
- Use of oral (estrogen and/or progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have...
- In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have...
- Pregnant or lactating women.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug, at investigator's discretion.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Patients considered unsuitable for the study, including patients with psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol...
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.