NCT03480568 is a Phase 3 clinical trial of Alirocumab 150 MG/ML [Praluent] in Hemodialysis, sponsored by Baylor Research Institute.

Who is sponsoring NCT03480568?

NCT03480568 is sponsored by Baylor Research Institute.

What drugs are being tested in NCT03480568?

Interventions in NCT03480568: Alirocumab 150 MG/ML [Praluent].

What condition does NCT03480568 study?

NCT03480568 studies Hemodialysis, Peritoneal Dialysis, Hypercholesterolemia, Atherosclerotic Disease.

Is NCT03480568 still recruiting?

NCT03480568 is currently status unknown. Last updated 12 February 2020.

Last reviewed 2020-02-12 · How we verify

NCT03480568

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Alirocumab in Patients on a Stable Dialysis Regimen

Status unknown Phase 3 Last updated 12 February 2020

What this trial tests

Phase 3 trial testing Alirocumab 150 MG/ML [Praluent] in Hemodialysis in 20 participants. Status unknown.

Timeline

1 May 2018

Primary endpoint
31 August 2020

31 December 2020

Quick facts

Lead sponsor	Baylor Research Institute
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 May 2018
Primary completion	31 August 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

Alirocumab 150 MG/ML [Praluent] — full drug profile →

Conditions studied

Hemodialysis — all drugs for Hemodialysis →
Peritoneal Dialysis — all drugs for Peritoneal Dialysis →
Hypercholesterolemia — all drugs for Hypercholesterolemia →
Atherosclerotic Disease — all drugs for Atherosclerotic Disease →

Sponsor

Baylor Research Institute

Who can join

Adults 18 to 80, any sex, with Hemodialysis or Peritoneal Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update.
Kaddoura R, Orabi B, Salam AM. · · 2020 · cited 18× · PMID 32939318 · DOI 10.1080/21556660.2020.1801452
Alirocumab and Lipid Levels, Inflammatory Biomarkers, Metabolomics, and Safety in Patients Receiving Maintenance Dialysis: The ALIrocumab in DIALysis Study (A Phase 3 Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen).
East C, Bass K, Mehta A, Rahimighazikalayed G, et al · · 2022 · cited 12× · PMID 35801187 · DOI 10.1016/j.xkme.2022.100483

Verify or expand the search:

Other recruiting trials for Hemodialysis

Currently open trials in the same condition.

NCT07278973 — Hemodiafiltration Versus Hemodialysis in Older People · NA · recruiting
NCT07438925 — Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation · active not recruiting
NCT07234890 — Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury. · Phase 2 · recruiting
NCT07512895 — The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treat · NA · recruiting
NCT07076888 — Aerobic Exercises and Hemodialysis Patients · NA · recruiting

Other Baylor Research Institute trials

Trials by the same sponsor.

NCT07467720 — Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial · NA · not yet recruiting
NCT07547878 — Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) · Phase 4 · not yet recruiting
NCT07460583 — ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes · NA · not yet recruiting
NCT07096544 — CALM Study: Cardiomems Assisted Lvad Management · NA · not yet recruiting
NCT07220395 — eHealth Literacy Intervention for Spanish Speaking Older Adults in the US · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03480568 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baylor Research Institute
Last refreshed: 12 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03480568.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing