Alirocumab for Heart Transplant Rejection

(CAVIAR Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Impaired liver function

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 26

Duration: 52 weeks

120 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug Alirocumab differ from other treatments for heart transplant rejection?

Alirocumab is unique because it is primarily used to lower cholesterol by inhibiting a protein called PCSK9, which is different from traditional immunosuppressive drugs used in transplant rejection that target the immune system directly. This novel mechanism may offer a new approach to managing heart transplant rejection, although its specific effects in this context are still being studied. ^{1 2 3 4 5}

What is the purpose of this trial?

The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.

Research Team

William Fearon, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals who have recently received a heart transplant. Participants must not have impaired liver function to be eligible.

Inclusion Criteria

I have received a heart transplant.

Exclusion Criteria

My liver isn't working properly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alirocumab or placebo every other week for one year following heart transplantation

52 weeks

26 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Alirocumab

Trial Overview The study tests the safety and effect of alirocumab, a PCSK9 inhibitor, on preventing blood vessel disease in the new heart compared to a placebo (inactive substance).

Participant Groups

Group I: alirocumab Experimental Treatment 1 Intervention

alirocumab 150mg subcutaneous every other week for one year following start of study drug

Group II: placebo Placebo Group 1 Intervention

placebo to match alirocumab every other week for one year following start of study drug

Alirocumab is already approved in European Union, United States for the following indications:

Approved in European Union as Praluent for:

• High cholesterol - Familial Homozygous
• Cardiovascular Risk Reduction
• High cholesterol - Familial Heterozygous
• High Cholesterol

Approved in United States as Praluent for:

• High cholesterol - Familial Homozygous
• Cardiovascular Risk Reduction
• High cholesterol - Familial Heterozygous
• Primary hyperlipidemia

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. England pubmed.ncbi.nlm.nih.gov

CCR5 blockade in combination with rapamycin prolongs cardiac allograft survival in mice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Combined Anti-CD154/CTLA4Ig Costimulation Blockade-Based Therapy Induces Donor-Specific Tolerance to Vascularized Osteomyocutaneous Allografts. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Studies Introducing Costimulation Blockade for Vascularized Composite Allografts in Nonhuman Primates. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Immunomodulatory effects of BXL-01-0029, a less hypercalcemic vitamin D analogue, in human cardiomyocytes and T cells. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Single dose anti-CD4 monoclonal antibody for induction of tolerance to cardiac allograft in high- and low-responder rat strain combinations. [2019]