120 Participants Needed

Maraviroc for Primary Graft Dysfunction

(MARAVIROC Trial)

DR
Overseen ByDaniel R Calabrese, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Francisco
Must be taking: Tacrolimus, Mycophenolate, Prednisone
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will be on a routine maintenance immunosuppression regimen including tacrolimus, mycophenolate, and prednisone.

How is the drug Maraviroc unique for treating primary graft dysfunction?

Maraviroc is unique because it is primarily known as an HIV medication that blocks the CCR5 receptor, which is different from other treatments like levosimendan, a calcium sensitizer used for heart function. This novel mechanism may offer a new approach to managing primary graft dysfunction, which currently lacks a standard treatment.12345

What is the purpose of this trial?

Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1/3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD.The goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are:To address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body.This will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives.Participants will:Take drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.

Research Team

DC

Daniel Calabrese, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for lung transplant patients over 18 with a high risk of primary graft dysfunction (PGD). They must have a PGD risk score above 50%. The study excludes certain individuals, but specific exclusion criteria are not provided.

Inclusion Criteria

I am 18 years or older and on the lung transplant waitlist.
My risk of lung transplant rejection is over 50%.
Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
See 2 more

Exclusion Criteria

I am scheduled for a treatment that reduces my immune cells.
I am receiving an organ from a donor with HIV, HCV, or HBV.
Recipient listed for concurrent heart or other solid organ transplantation
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Maraviroc or placebo every 12 hours for 3 days post-surgery

3 days
Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment during their hospital stay and have a single follow-up visit 12 months post-discharge

16 days in-hospital, 12 months post-discharge
In-hospital monitoring, 1 follow-up visit (in-person)

Long-term Follow-up

Participants are monitored for mortality and other long-term outcomes

12 months

Treatment Details

Interventions

  • Maraviroc
Trial Overview The trial tests Maraviroc, an FDA-approved drug that may prevent lung injury after a transplant. It's compared to a placebo in a double-blind setup where neither doctors nor patients know who gets the real drug. Participants take their assigned treatment every 12 hours for three days post-surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MaravirocExperimental Treatment1 Intervention
This arm is the Maraviroc drug which will be administered to patients.
Group II: PlaceboPlacebo Group1 Intervention
This arm is the placebo drug which will be matched in appearance and taste to the Maraviroc and is available in PO and liquid (PFT) formulations.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

References

Levosimendan for Treatment of Primary Graft Dysfunction After Heart Transplantation: Optimal Timing of Application. [2022]
Primary Graft Dysfunction: Factor V's Value for Its Early Diagnosis. [2022]
Experience of ECMO in primary graft dysfunction after orthotopic heart transplantation. [2018]
PREDICTA: A Model to Predict Primary Graft Dysfunction After Adult Heart Transplantation in the United Kingdom. [2020]
Associated Clinical and Laboratory Markers of Donor on Allograft Function After Heart Transplant. [2018]
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