Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
ID03480568

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

Led by Baylor Research Institute · Updated on 2020-02-12

20

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

B

Baylor Research Institute

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of alirocumab, given every two weeks for 12 weeks, on cholesterol levels in patients who are stably maintained on hemodialysis or peritoneal dialysis. The study focuses on patients with end-stage renal disease receiving dialysis and seeks to demonstrate the drug's impact on lowering LDL cholesterol and other biomarkers. The trial also monitors safety and drug levels in this specific patient population. Participants receive alirocumab 150 mg administered by subcutaneous injection every two weeks for a total of 12 weeks. The study includes two groups of patients: ten on hemodialysis and ten on peritoneal dialysis, all having been stable on their dialysis regimen for at least three months. The open-label design means all enrolled patients receive the drug without placebo comparison. Throughout the study, cholesterol levels, including LDL, HDL, and apoprotein B, are measured at baseline and at weeks 4, 8, and 12. Additional biomarkers and routine lab tests are also collected to assess safety and drug effects. Safety is closely monitored by recording adverse events and clinical changes during the entire 12-week treatment period. This allows researchers to understand how alirocumab affects cholesterol and related markers in dialysis patients under stable treatment conditions.

CONDITIONS

Brief Title

Alirocumab in Patients on a Stable Dialysis Regimen

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients, ages 18 to 80 years.
  • Written informed consent obtained before any study assessment.
  • Diagnosis of end-stage renal disease, maintained on dialysis without complications for at least 3 months.
  • Patients may have a history of atherosclerotic disease such as MI, PCI, CABG, TIA, CVA, or PAD.
  • Enrollment includes 10 patients on hemodialysis and 10 patients on peritoneal dialysis.
Not Eligible

You will not qualify if you...

  • LDL-cholesterol level below 70 mg/dL.
  • Any contraindication to subcutaneous injections.
  • Ongoing statin and/or ezetimibe therapy must remain unchanged during the study.
  • History of allergy or intolerance to the study drug or similar drugs.
  • History of MI, PCI, CABG, TIA, CVA, or PAD within 3 months before enrollment.
  • History of malignant cancer within the past 3 years, excluding basal cell skin cancer or cervical cancer in situ.
  • Women of child-bearing potential not using effective contraception during and 2 weeks after dosing.
  • Pregnant or lactating women.
  • Medical conditions affecting drug absorption or metabolism as judged by the investigator.
  • History or evidence of drug or alcohol abuse within the last 12 months.
  • Psychiatric, behavioral, or cognitive disorders interfering with protocol compliance or follow-up.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive alirocumab 150 mg by subcutaneous injection every 2 weeks for 12 weeks.

Biweekly visits for injections over 12 weeks

Trial Site Locations

Total: 1 location

1

Baylor Soltero CV Research

Dallas, Texas, United States, 75226

Actively Recruiting

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Research Team

C

Cara East, MD

M

Merielle Boatman

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Marije van der Velde, Kunihiro Matsushita, Josef Coresh...

https://pubmed.ncbi.nlm.nih.gov/21307840

Inverse association between lipid levels and mortality in men with chronic kidney disease who are not yet on dialysis: effects of case mix and the malnutrition-inflammation-cachexia syndrome.

Csaba P Kovesdy, John E Anderson, Kamyar Kalantar-Zadeh

https://pubmed.ncbi.nlm.nih.gov/17167114

Long-term effects following 4 years of randomized treatment with atorvastatin in patients with type 2 diabetes mellitus on hemodialysis.

Vera Krane, Kay-Renke Schmidt, Lena J Gutjahr-Lengsfeld...

https://pubmed.ncbi.nlm.nih.gov/26924051