Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alirocumab in Patients on a Stable Dialysis Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480568
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemodialysis Peritoneal Dialysis Hypercholesterolemia Atherosclerotic Disease Drug: Alirocumab 150 MG/ML [Praluent] Phase 3

Detailed Description:

Primary objective: The objective of this trial is to demonstrate the efficacy of alirocumab 150 mg every 2 weeks over 12 weeks on cholesterol levels.

Secondary objective: To assess the safety of treating chronic dialysis patients with alirocumab 150 mg subcutaneously every 2 weeks for 12 weeks.

Secondary objective: To demonstrate the efficacy of alirocumab 150 mg every 2 weeks over 12 weeks on biomarkers.

Exploratory objective: To assess alirocumab drug levels in subjects maintained on hemodialysis and peritoneal dialysis.

Methodology: Open-label, nonrandomized study

Number of patients Ten patients maintained on stable hemodialysis for a minimum of 3 months and ten patients maintained on stable peritoneal dialysis for a minimum of 3 months

Test product: alirocumab 150 mg

Mode of administration: administered subcutaneously

Dosing interval: every 2 weeks

Duration of treatment: 12 weeks

Primary endpoint: Levels of LDL-cholesterol at 12 weeks

Secondary endpoints: Levels of total cholesterol, triglycerides, apoprotein B, Cystatin-C, fibrinogen, hsCRP, IL-6, NGAL, NT-proBNP, soluble CD40 ligand, troponin T, VCAM

Safety criteria: Adverse events, Incidence and intensity of AE, including serious AE (SAE), Withdrawal from study medication due to AE, Clinical relevant new findings or worsening of existing conditions physical examination, Clinically relevant changes in laboratory measurements from baseline


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, nonrandomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen: The Alidial Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: alirocumab
Alirocumab 150 mg q 2 weeks for 12 weeks
Drug: Alirocumab 150 MG/ML [Praluent]
Cholesterol-lowering therapy




Primary Outcome Measures :
  1. Change in LDL cholesterol levels [ Time Frame: Baseline, 4 ,8, 12 weeks ]
    Efficacy


Secondary Outcome Measures :
  1. Change in HDL-cholesterol levels [ Time Frame: Baseline, 12 weeks ]
    Efficacy

  2. Change in apoprotein B levels [ Time Frame: Baseline, 4, 8, 12 weeks ]
    Efficacy


Other Outcome Measures:
  1. Change in PCSK9 levels [ Time Frame: Baseline, 4, 8, 10, 12 weeks ]
    Efficacy

  2. Change in alirocumab drug levels [ Time Frame: Baseline, 4, 8, 10, 12 weeks ]
    Efficacy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients, ages 18 to 80 years.
  2. Written informed consent will be obtained before any study assessment is performed.
  3. Diagnosis of end-stage renal disease, maintained on dialysis, without dialysis complications, for at least 3 months.
  4. 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).
  5. A total of 20 patients will be enrolled, 10 patients on hemodialysis and 10 patients on peritoneal dialysis.

Exclusion Criteria:

  1. LDL-cholesterol level of < 70 mg/dL.
  2. Any contraindication to subcutaneous injections.
  3. Patients on statin and/or ezetimibe therapy will have their cholesterol-lowering therapy continued as is without change during the time of the study.
  4. History of any allergy or intolerance to the study drug or drugs of the same class.
  5. A history of MI, PCI, CABG surgery, TIA, CVA, or PAD events within 3 months of enrollment.
  6. History of malignant cancer within the past 3 years, excepting basal cell skin cancer or cervical cancer in situ.
  7. 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 last injection of the drug. Highly effective methods of contraception include:

    1. 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 methods of contraception.
    2. 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 status of the woman has been confirmed by follow-up hormone level assessment.
    3. 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.
    4. 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 comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.
    5. 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.
    6. 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 had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before enrollment.
  8. Pregnant or lactating women.
  9. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug, at investigator's discretion.
  10. History or evidence of drug or alcohol abuse within the last 12 months.
  11. 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 instructions or follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480568


Contacts
Layout table for location contacts
Contact: Cara East, MD 214-820-2273 cara.east@bswhealth.org
Contact: Merielle Boatman 214-820-2273 merielle.boatman@bswhealth.org

Locations
Layout table for location information
United States, Texas
Baylor Soltero CV Research Recruiting
Dallas, Texas, United States, 75226
Contact: Cara East, MD    214-820-2273    cara.east@bswhealth.org   
Contact: Merielle Boatman    214-820-2273    merielle.boatman@bswhealth.org   
Principal Investigator: Cara East, MD         
Sponsors and Collaborators
Baylor Research Institute
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Cara East, MD Baylor Research Institute

Additional Information:
Publications of Results:
van der Velde M, Matsushita K, Coresh J, Astor BC, Woodward M, Levey A, de Jong P, Gansevoort RT; Chronic Kidney Disease Prognosis Consortium, van der Velde M, Matsushita K, Coresh J, Astor BC, Woodward M, Levey AS, de Jong PE, Gansevoort RT, Levey A, El-Nahas M, Eckardt KU, Kasiske BL, Ninomiya T, Chalmers J, Macmahon S, Tonelli M, Hemmelgarn B, Sacks F, Curhan G, Collins AJ, Li S, Chen SC, Hawaii Cohort KP, Lee BJ, Ishani A, Neaton J, Svendsen K, Mann JF, Yusuf S, Teo KK, Gao P, Nelson RG, Knowler WC, Bilo HJ, Joosten H, Kleefstra N, Groenier KH, Auguste P, Veldhuis K, Wang Y, Camarata L, Thomas B, Manley T. Lower estimated glomerular filtration rate and higher albuminuria are associated with all-cause and cardiovascular mortality. A collaborative meta-analysis of high-risk population cohorts. Kidney Int. 2011 Jun;79(12):1341-52. doi: 10.1038/ki.2010.536. Epub 2011 Feb 9.
6. KDIGO clinical practice guideline for lipid management in chronic kidney disease. Kidney Int Suppl. 2013;3:259-286.
Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellström B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Grönhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.

Layout table for additonal information
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03480568     History of Changes
Other Study ID Numbers: 018-038
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will provide data upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: within 6 weeks of request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Baylor Research Institute:
Alirocumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs