Alirocumab in Patients on a Stable Dialysis Regimen

February 10, 2020 updated by: Baylor Research Institute

A Phase III Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen: The Alidial Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL cholesterol levels
Time Frame: Baseline, 4 ,8, 12 weeks
Efficacy
Baseline, 4 ,8, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HDL-cholesterol levels
Time Frame: Baseline, 12 weeks
Efficacy
Baseline, 12 weeks
Change in apoprotein B levels
Time Frame: Baseline, 4, 8, 12 weeks
Efficacy
Baseline, 4, 8, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PCSK9 levels
Time Frame: Baseline, 4, 8, 10, 12 weeks
Efficacy
Baseline, 4, 8, 10, 12 weeks
Change in alirocumab drug levels
Time Frame: Baseline, 4, 8, 10, 12 weeks
Efficacy
Baseline, 4, 8, 10, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Cara East, MD, Baylor Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Will provide data upon request

IPD Sharing Time Frame

within 6 weeks of request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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