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PCSK-9 Inhibitor

Evolocumab for High Cholesterol in Kidney Transplant Patients

Phase 4
Recruiting
Led By Anil K Chandraker, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult renal transplant recipients greater than 1-year post-transplantation, men and women between 18 and 85 years of age, inclusive
Any patient with documented ASCVD or diabetes and 1 or more risk factors for ASCVD, including, but not limited to obesity, inactive lifestyle, hypertension, smoking, and family history, and an LDL >70 mg/dl (Highest-Risk Patients)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new cholesterol-lowering drug in kidney transplant patients to see if it is safe and tolerable.

Who is the study for?
This trial is for adult kidney transplant recipients (1+ year post-transplant), aged 18-85, with high cholesterol or diabetes plus other heart disease risk factors. It's not for those in another trial, currently facing organ rejection, pregnant, or planning pregnancy within a year.Check my eligibility
What is being tested?
The study tests Evolocumab's safety and effectiveness in managing cholesterol levels after kidney transplantation. Participants will receive this PCSK-9 inhibitor to see if it lowers lipid levels without the side effects common with statins.See study design
What are the potential side effects?
Evolocumab may cause allergic reactions, muscle pain, liver toxicity similar to statins but could be safer for kidneys. Side effects vary; some patients might experience none while others could have more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old and had a kidney transplant over a year ago.
Select...
I have heart disease or diabetes, at least one other risk factor for heart disease, and my LDL is over 70 mg/dl.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change from baseline in the LDL cholesterol level
Secondary outcome measures
absolute change from baseline in the LDL cholesterol level

Trial Design

2Treatment groups
Experimental Treatment
Group I: Evolocumab plus statinExperimental Treatment2 Interventions
This arm includes subjects who are treated using a combination of Evolocumab and a statin-based drug.
Group II: Evolocumab onlyExperimental Treatment1 Intervention
This arm includes subjects who are treated using Evolocumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Statins (Cardiovascular Agents)
2019
Completed Phase 3
~480
Evolocumab
2011
Completed Phase 4
~13010

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,362 Previous Clinical Trials
1,385,151 Total Patients Enrolled
2 Trials studying High Cholesterol
1,990 Patients Enrolled for High Cholesterol
Brigham and Women's HospitalLead Sponsor
1,602 Previous Clinical Trials
11,463,105 Total Patients Enrolled
Anil K Chandraker, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Evolocumab (PCSK-9 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04608474 — Phase 4
High Cholesterol Research Study Groups: Evolocumab plus statin, Evolocumab only
High Cholesterol Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT04608474 — Phase 4
Evolocumab (PCSK-9 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04608474 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~29 spots leftby Mar 2025