Evolocumab In Advanced Chronic Kidney Disease Trial

Part of paid clinical trials in Mineola, New York.

Sponsor
NYU Langone Health
Study ID
NCT04510844
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab is commercially available in the United States and is manufactured by Amgen. Drug and placebo, will be supplied by the manufacturer. The SureClick® pre-filled auto injector contain Evolocumab (140 mg) acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in water for Injection. Evolocumab will be administered at a dose of 420 mg subcutaneously once monthly.
  • Placebo — OTHER
    Placebo will be supplied by the manufacturer. Placebo auto injectors will be identically packaged but will lack the active ingredient. Placebo will be administered at an equivalent volume to Evolocumab and given subcutaneously once monthly.

Study Details

110 individuals with stage 4-5 Chronic Kidney Disease (CKD) will be randomized to 1-year of blinded Evolocumab or placebo. Subjects will undergo evaluation of circulating lipids at baseline and end of study. A substudy including 50 subjects will assess myocardial rest and stress positron emission tomography (PET) at baseline and at 1-year.

Key Dates

Start date
Mar 1, 2021
Status verified
Jul 2022
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Drug Group
    Participants who will receive a shot of the Evolocumab at Visit 3 and self-administer the rest of the shots at visit 4-7.
  • Placebo Comparator: Placebo group
    Participants who will receive a Placebo shot at Visit 3 and self-administer the rest of the shots at visit 4-7.

Primary Outcome Measure

Absolute change in LDL cholesterol concentration [ Time Frame: Baseline, Week 52 ]

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone Nephrology Associates - Long IslandMineolaNew York11501-
NYU Langone HealthNew YorkNew York10010-

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By research site
NYU Langone Nephrology Associates - Long Island· Mineola, NYNYU Langone Health· New York, NY

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