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Evolocumab In Advanced Chronic Kidney Disease Trial | Clinical Trials | Clareo Health

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Evolocumab In Advanced Chronic Kidney Disease Trial

A Phase IV, Double-Blind, Placebo-Controlled, Multi-Center Trial To Study The Effects Of Evolocumab In Stage IV-V Chronic Kidney Disease: The Cardiovascular and Lipid-Lowering Effects Of Evolocumab In Advanced Chronic Kidney Disease Trial

NCT04510844•NYU Langone Health

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The purpose of this study is to evaluate the effect of evolocumab (Repatha®)-a Food and Drug Administration (FDA)-approved biological drug that has been shown to reduce LDL cholesterol (bad cholesterol) Early data show that the beneftis of evolocumab may be increased as kidney function declines. This trial is therefore designed to provide additional evidence regarding the safety and cholesterol-lowering effects of evolocumab compared with placebo, a pill that has no therapeutic effect, in advanced CKD patients.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•CKD Stage 4-5 defined as
•* eGFR ≤30 mL/min/1.73m2 on screening lab OR
•* Treatment with maintenance hemodialysis for at least 30 days prior to screening
•LDL ≥70 mg/dL and
•* Treatment with maximal tolerated doses of a statin OR
•* Statin intolerance defined as any history of intolerance or allergy to ≥1 statin
•Age 40-80 years
•* Individuals ≤60 years old are required to have ≥1 of the following cardiovascular risk factors:
•* History of CV disease
•* History of peripheral vascular disease
+4 more criteria

Exclusion Criteria

•Age \>80 years
•Expected survival \< 1 year
•Transplant expected within \< 1 year
•Active liver disease (history of cirrhosis, ALT or AST \> 2x ULN)
•CPK \> 5x ULN at screening
•Malignancy within 5 years except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma
•Subject has received drugs that are strong inhibitors of cytochrome P-450 3A4 within 1 month prior to randomization or is likely to require such treatment during the study period
•Currently enrolled in another interventional study
•Female subject who has not used at least (1) effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal.
•* Effective measures of birth control include surgical sterilization, barrier methods, hormonal contraceptives and intrauterine devices.
+11 more criteria

Locations (2)

NYU Langone Nephrology Associates - Long Island

Mineola, New York, United States

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

March 1, 2021

Primary Completion Date

October 1, 2021

Completion Date

October 1, 2021

Last Updated

July 28, 2022

Conditions

Chronic Kidney DiseasesHigh Cholesterol

Interventions

Evolocumab

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evolocumab In Advanced Chronic Kidney Disease Trial

Inclusion Criteria

Exclusion Criteria

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