A Phase 4 interventional study of Evolocumab in Hyperlipidemias, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment
Cardiovascular disease is the leading cause of mortality after renal transplantation, accounting for more than 30% of deaths. Elevated lipid levels (hyperlipidemia) are a frequent finding following transplantation and the immunosuppressive medications play a central role in the development or worsening of hyperlipidemia. In the general population, the correlation between elevated serum cholesterol and increased risk of cardiovascular disease is well established and the reduction in serum LDL cholesterol has proved to significantly reduce both morbidity and mortality.
Statin based drugs are the standard of care in the management of hyperlipidemia. Commonly used statin-based drugs include atorvastatin (Lipitor), fluvastatin (Lescol, Lescol XL), lovastatin (Mevacor, Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and pitavastatin (Livalo). These drugs have been proven to lower lipid levels as well as cardiovascular risk. However, statin-based drugs also cause a variety of side effects. While the most commonly encountered side effects are toxicity to the liver and muscles, a few others have also been known to cause increased excretion of protein in the urine and kidney failure. These side effects are also more common in a renal transplant recipient due to the simultaneous administration of drugs that prevent rejection. Therefore, there is an emergent need for newer drugs which are both efficient and safe especially in this population PCSK-9 inhibitors (Proprotein Convertase Subtilisin Kinase-9 inhibitors) are a new class of drugs that are highly efficient in lowering lipid levels in the general population. However, an exclusive trial involving kidney transplant recipients is yet to be done. Through this study, we would like to evaluate the safety and tolerability of Evolocumab (trade name: Repatha) which is a PCSK-9 inhibitor developed by Amgen, Inc in renal transplant recipients. The study would involve a total of 120 patients across 3 different hospitals in Boston, Massachusetts.
Cardiovascular disease is the leading cause of death in renal transplant recipients (RTR). 44% of RTR have LDL-C greater than 100mg/dL, six months after transplant. The correlation between the increase in serum LDL level and the increased risk of atherosclerotic cardiovascular disease (ASCVD) is well established. A reduction in LDL level is associated with a decreased risk of mortality and morbidity in patients with ASCVD. Statins have been the long-standing drug of choice in treating dyslipidemia. A single prospective randomized trial known as the ALERT trial compared the benefits of statins to placebo in transplant recipients. The original study consisted of 2000 RTR and an extension of this study evaluated 1652 patients and demonstrated a 21% reduction in major cardiac events (p=0.036) and a 29% reduction in cardiac death or definite non-fatal myocardial infarction (p=0.014). Even though statins decrease the probability of cardiovascular events there was no difference in graft survival or mortality benefit in RTR. Another concerning factor for the use of statins is the tolerability of these drugs. Statins have been associated with hepatotoxicity and myotoxicity, the incidence of which is higher in RTR. This effect is dose-related and may be precipitated by the administration of agents that inhibit cytochrome p450 isoenzymes such as Tacrolimus and Cyclosporine which are the most commonly used immunosuppressants. Another statin based drug (Fluvastatin) has been associated with proteinuria and renal failure. Hence there is a need to explore novel treatment options in the management of dyslipidemia, particularly in RTR. PCSK-9 inhibitors (Proprotein Convertase Subtilisin Kinase-9 inhibitors) have shown to decrease LDL levels by 60% in patients on statin therapy. However, these drugs have been studied sparingly in patients with Chronic Kidney Disease (CKD) and have not yet been analyzed in RTR.
The study will involve 120 patients across 3 different hospitals. Two different but equivalent drug dosing strategies are available. A 420mg monthly subcutaneous injection using an on-body infusor (Repatha Pushtronex system) or a 140mg subcutaneous injection once every two weeks using a prefilled auto-injector (Repatha SureClick). The choice of dosing strategy will be based on patient preference. This study will be conducted over one year.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's enrollment of 81 is close to the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received evolocumab for lipid lowering.
Drug: Evolocumab
Two different but equivalent drug dosing strategies are available. A 420mg monthly subcutaneous injection using an on-body infuser (Repatha Pushtronex system) or a 140mg subcutaneous injection once every two weeks using a prefilled auto-injector (Repatha SureClick). The choice of dosing strategy will be based on patient preference.
Also known as: Repatha
Percent Change in LDL Cholesterol From Baseline to 12 Months
The primary efficacy measure is the percent change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
Time frame: Baseline to 12 months (Month 0 to Month 12; assessment window Months 11-13)
Absolute Change in LDL Cholesterol From Baseline to 12 Months
Absolute change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
Time frame: Baseline to 12 months (Month 0 to Month 12; assessment window Months 11-13)
Number of Participants Achieving LDL Cholesterol < 70 mg/dL at Any Time During Follow-up
Number of participants who achieved LDL cholesterol \< 70 mg/dL at any time during follow-up.
Time frame: From baseline through Month 13
| Milestone | Evolocumab |
|---|---|
| Started | 81 |
| Completed | 50 |
| Not completed | 31 |
| Withdrew: Lost to follow-up | 15 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Adverse event | 5 |
| Withdrew: Physician decision | 2 |
The primary efficacy measure is the percent change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
| Percent (%) | Evolocumab |
|---|---|
| Percent Change in LDL Cholesterol From Baseline to 12 Months | -46.6 ± 25.9 |
Absolute change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
| mg/dL | Evolocumab |
|---|---|
| Absolute Change in LDL Cholesterol From Baseline to 12 Months | -61.8 ± 38.5 |
Number of participants who achieved LDL cholesterol \< 70 mg/dL at any time during follow-up.
| Participants | Evolocumab |
|---|---|
| Achieved LDL < 70 mg/dL | 46 |
| Did not achieve LDL < 70 mg/dL | 20 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evolocumab | 0/66 (0%) | 0/66 (0%) | 4/66 (6.1%) |
| Event | Evolocumab |
|---|---|
| Allergic Skin ReactionSkin and subcutaneous tissue disorders | 3/66 |
| Elevated Creatine KinaseInvestigations | 1/66 |
| Age, Continuous(years) | Evolocumab |
|---|---|
| Mean | 52.85 ± 12.34 |
| Sex: Female, Male(Participants) | Evolocumab |
|---|---|
| Female | 24 |
| Male | 46 |
| Ethnicity (NIH/OMB)(Participants) | Evolocumab |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 65 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Evolocumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 53 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| LDL Cholesterol, Baseline(mg/dL) | Evolocumab |
|---|---|
| Mean | 131.5 ± 30.9 |
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