Status:
WITHDRAWN
Evolocumab In Advanced Chronic Kidney Disease Trial
Lead Sponsor:
NYU Langone Health
Conditions:
Chronic Kidney Diseases
High Cholesterol
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief 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...
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 cholestero...
Eligibility Criteria
Inclusion
- 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
- Diabetes
- Smoking
- Baseline LDL ≥160 mg/dL
- Macroalbuminuria (albumin to creatinine ratio ≥300 mg/g on spot sample)
Exclusion
- 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.
- Pregnant or breast-feeding subjects
- Known sensitivity or intolerance to study medications
- The following additional criteria will be utilized to exclude individuals from participating in the PET substudy:
- Severe asthma or obstructive lung disease defined by
- Hospitalization for asthma or obstructive lung disease within 8 weeks
- Use of oral steroids for lung disease within 8 weeks
- Chronic oxygen therapy
- Use of rescue inhalers ≥three times weekly in the previous 4 weeks
- History of seizures
- Second or third-degree AV block, unless a functioning pacemaker is present
- Sinus node dysfunction unless a functioning pacemaker is present
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04510844
Start Date
March 1 2021
End Date
October 1 2021
Last Update
July 28 2022
Active Locations (2)
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1
NYU Langone Nephrology Associates - Long Island
Mineola, New York, United States, 11501
2
NYU Langone Health
New York, New York, United States, 10010