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New hope for kidney transplant patients: cholesterol drug evolocumab shows promise

NCT ID NCT04608474

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested the drug evolocumab (Repatha) in 81 kidney transplant recipients with high cholesterol. The goal was to see if it could safely lower cholesterol levels, since standard statin drugs often cause side effects in these patients. The results could lead to a better way to manage heart disease risk after a kidney transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
evolocumab (Repatha)
What this could lead to
If successful, this could provide a safer cholesterol-lowering option for kidney transplant patients, reducing their heart disease risk.
What could go wrong
This is a small pilot study with only 81 participants, so results may not apply to everyone. The drug's long-term safety in transplant recipients is still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

81 people

The number who actually took part.

Started

Feb 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemias

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.