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Immunosuppressant

Envarsus for Heart Transplant Rejection (Veloxis Trial)

Phase 2

Waitlist Available

Led By Shelley Hall, MD, FACC, FHFSA

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Heart-only transplant recipients

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Veloxis Trial Summary

This trial will compare the effectiveness of two different tacrolimus regimens in people who have had a heart transplant.

Who is the study for?

This trial is for adults over 18 who have had a heart-only transplant and can follow the medication plan. They must understand and sign consent forms. It's not for those in other trials, taking certain immune drugs, with multiple organ transplants, liver transplant needs, or allergies to tacrolimus.Check my eligibility

What is being tested?

The study compares Envarsus®, an extended-release form of tacrolimus taken once daily, with Prograf®, the standard twice-daily version. The goal is to see if Envarsus® works as well after heart transplantation.See study design

What are the potential side effects?

Tacrolimus may cause side effects like kidney problems, high blood pressure, tremors, increased risk of infections and diabetes. Extended-release versions might differ in how these side effects present.

Veloxis Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have had a heart transplant only.

Veloxis Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rejection and Graft Failure

Secondary outcome measures

Therapeutic immunosuppression

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589

98%

Anemia

83%

Hypomagnesemia

75%

Leukopenia

70%

Hyperkalemia

57%

Abnormal renal function

50%

Hypophosphatemia

50%

Increase creatinine

45%

Hyperglycemia

33%

Delayed Graft Function Requiring Dialysis

30%

Diarrhea

30%

Nausea

28%

Headache

28%

Hypertension

25%

Tremor

25%

Infection

23%

Constipation

23%

Edema

20%

Vomiting

18%

Hyperlipidemia

18%

Hypokalemia

10%

Biopsy Proven Acute Rejection

Neurotoxicity

Graft loss

100%

80%

60%

40%

20%

Study treatment Arm

CYP3A5 Based Tacrolimus Dosing

Control

Veloxis Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ProspectiveExperimental Treatment1 Intervention

25 adult male or female recipients of a heart transplant will be prospectively enrolled to once-daily therapy with Envarsus tablets. Time of initiation will follow current standard of care.

Group II: RetrospectiveActive Control1 Intervention

25 age/gender-matched subjects who are receiving twice daily dosing with Prograf will be identified from the transplant center database and contacted to be consented, after which their results will be analyzed retrospectively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

FDA approved

0 / 1Eligibility criteria met