Managing cholesterol levels in kidney transplant patients using Evolocumab
Lipid Management in Renal Transplant Recipients: A Pilot Study Evaluating the Use of PCSK-9 Inhibitor, Evolocumab.
This study tests if a cholesterol-lowering medication called Evolocumab can help kidney transplant patients with high cholesterol feel better and lower their heart risks compared to standard treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | Evolocumab |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04608474 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Evolocumab, a cholesterol-lowering medication, in renal transplant recipients who often experience elevated lipid levels post-transplant. The study focuses on patients with hyperlipidemia, particularly those with a history of cardiovascular disease or diabetes. By comparing the outcomes of Evolocumab treatment against standard statin therapy, the trial aims to assess improvements in lipid profiles and potential reductions in cardiovascular risks. The study includes adult participants aged 18 to 85 who are more than one year post-transplant and have specific LDL cholesterol levels.
Who should consider this trial
Good fit: Ideal candidates for this study are adult renal transplant recipients over one year post-transplant with elevated LDL cholesterol levels.
Not a fit: Patients currently experiencing cellular or antibody-mediated rejection or those with serious hypersensitivity to Evolocumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing high cholesterol in kidney transplant recipients, potentially reducing their risk of cardiovascular disease.
How similar studies have performed: Previous studies have shown that statin therapy can reduce cardiovascular events in renal transplant recipients, but this approach using Evolocumab is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * Any patient not classified as one of our highest-risk patients, that has an LDL \>100 mg/dl Exclusion Criteria: * Patients currently enrolled in another interventional clinical trial. * Patients being actively treated for cellular or antibody-mediated rejection. * Serious hypersensitivity to Evolocumab or any component of the formulation. * Patients who are pregnant or planning a pregnancy in the next one year.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Anil K Chandraker, MD — Brigham and Women's Hospital
- Study coordinator: Anil K Chandraker, MD
- Email: achandraker@bwh.harvard.edu
- Phone: 617-732-7412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.