Evolocumab In Advanced Chronic Kidney Disease Trial

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Evolocumab

Criteria

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

• Diabetes

• Smoking

• Baseline LDL ≥160 mg/dL

• Macroalbuminuria (albumin to creatinine ratio ≥300 mg/g on spot sample)

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.

• 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