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Evolocumab for High Cholesterol in Kidney Transplant Patients
Study Summary
This trial is testing a new cholesterol-lowering drug in kidney transplant patients to see if it is safe and tolerable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- You have had a severe allergic reaction to Evolocumab or any of its ingredients.I am between 18 and 85 years old and had a kidney transplant over a year ago.I have heart disease or diabetes, at least one other risk factor for heart disease, and my LDL is over 70 mg/dl.I am currently receiving treatment for organ rejection.You are not considered one of the highest-risk patients and have LDL cholesterol levels higher than 100 mg/dl.
- Group 1: Evolocumab plus statin
- Group 2: Evolocumab only
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is eligible to take part in this medical experiment?
"This trial is seeking 120 individuals of ages 18 to 85 with elevated cholesterol levels. The following salient factors must be met by applicants: a record of ASCVD or diabetes and at least one associated risk factor (such as obesity, lack of exercise, hypertension, smoking history, familial predisposition); LDL > 70 mg/dl in the highest-risk cases; adults who have undergone kidney transplantation for more than 12 months; men and women aged between 18 - 85 years old; and those not classified as high-risk but still possessing an LDL > 100mg/dl."
What is the scope of enrolment for this clinical trial?
"Affirmative. According to the information listed on clinicaltrials.gov, this medical study, initially posted in February of 2021 is currently recruiting patients. Currently 120 volunteers are needed for a single centre trial."
Is this an unprecedented clinical trial?
"Since 2018, Statins (Cardiovascular Agents) has been studied in clinical trials. The first trial was sponsored by Hoffmann-La Roche and included 435 participants. After this initial study, the drug received Phase 1 & 2 approval from governing bodies. Nowadays there are 22 active trials for Statins (Cardiovascular Agents), spread across 35 countries with a presence in 240 cities worldwide."
Are there opportunities to enroll in this experiment currently?
"Affirmative. According to clinicaltrials.gov, this medical investigation began recruiting on February 17th 2021 and is presently seeking participants for its research program. 120 individuals are needed at one site in total."
Is this experimental procedure open to participants of 45 years and older?
"This trial is enrolling people aged 18 or older, but not exceeding 85 years old."
Is the use of Statins (Cardiovascular Agents) in patients associated with any adverse effects?
"Statins (Cardiovascular Agents) have already been approved, so it scored a 3 on our team's safety rating scale."
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