Chronic Kidney DiseasesPhase 4EVO-CKDNCT04510844
Evolocumab In Advanced Chronic Kidney Disease Trial
A Phase 4 study testing Evolocumab in people with Chronic Kidney Diseases and High Cholesterol, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, High Cholesterol
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2021to 1 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Nephrology Associates - Long Island
Mineola, New York, 11501
NYU Langone Health
New York, New York, 10010
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, High Cholesterol
- Being tested
- Evolocumab, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Study Drug Group | Experimental | Participants who will receive a shot of the Evolocumab at Visit 3 and self-administer the rest of the shots at visit 4-7. Receives: Drug: Evolocumab |
| Placebo group | Placebo comparator | Participants who will receive a Placebo shot at Visit 3 and self-administer the rest of the shots at visit 4-7. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in LDL cholesterol concentration
The primary endpoint is selected to evaluate the key pharmacologic mechanism underlying Evolocumab's cardiovascular benefits. This will be analyzed with Lipid parameters.
Measured: Baseline, Week 52
Secondary outcomes (2)
Number of Serious Adverse Events (SAEs)
Measured: Baseline, Week 52
Change in coronary flow reserve (CFR)
Change in coronary flow reserve (CFR), the key secondary efficacy endpoint, is a measure of overall cardiovascular health.This test provides an integrative measure of myocardial microvascular supply and myocardial endothelial function as well as large vessel coronary flow. Change in coronary flow reserve over one year as measured by cardiac PET scanning.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Why it stopped: loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Charytan, MD, Principal investigator, NYULangone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510844
- Sponsor's protocol ID
- 20-00405
- Other IDs
- 21-00455
- Acronym
- EVO-CKD
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04510844
- Acronym / sponsor ID
- EVO-CKD / 20-00405
- Conditions
- Chronic Kidney Diseases, High Cholesterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: loss of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug Group | Experimental | Drug: EvolocumabParticipants who will receive a shot of the Evolocumab at Visit 3 and self-administer the rest of the shots at visit 4-7. |
| Placebo group | Placebo comparator | Other: PlaceboParticipants who will receive a Placebo shot at Visit 3 and self-administer the rest of the shots at visit 4-7. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- CKD Stage 4-5 defined as
- LDL ≥70 mg/dL and
- Age 40-80 years
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabEvolocumab 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. | Drug | Study Drug Group |
| PlaceboPlacebo 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. | Other | Placebo group |
Primary outcome
Absolute change in LDL cholesterol concentration
Time frame: Baseline, Week 52
The primary endpoint is selected to evaluate the key pharmacologic mechanism underlying Evolocumab's cardiovascular benefits. This will be analyzed with Lipid parameters.
2 secondary outcomes
Number of Serious Adverse Events (SAEs)
Time frame: Baseline, Week 52
Change in coronary flow reserve (CFR)
Time frame: Baseline, Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Charytan, MD principal investigator
NYULangone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab in people with Chronic Kidney Diseases and High Cholesterol, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in LDL cholesterol concentration (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.