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Immunosuppressant

Belatacept + Everolimus for Kidney Transplant Rejection (BETTER Trial)

Phase 4

Waitlist Available

Led By Rita R Alloway, PharmD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

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

Must have

Patient who is receiving a renal transplant from a living or heart-beating deceased donor.

Patient who is receiving a renal transplant from a living or heart-beating deceased donor

Must not have

Patient has a known hypersensitivity to belatacept, tacrolimus, mycophenolate mofetil/mycophenolic acid, everolimus, rabbit anti-thymocyte globulin, or glucocorticoids

Patient has received an ABO incompatible donor kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 30 Other Conditions

Drug Has Already Been Approved

Summary

This trial is designed to see if 2 new calcineurin inhibitor free treatment groups are safe and more effective than a historical control group in renal transplant recipients.

Who is the study for?

Adults over 18 years old receiving a kidney transplant from living or deceased donors can join this trial. They must not have certain viral infections, uncontrolled conditions, or recent cancer history. Women of childbearing age need a negative pregnancy test and must use reliable contraception.

What is being tested?

The BETTER Trial is testing two drug regimens without calcineurin inhibitors for preventing kidney transplant rejection: one combines belatacept with everolimus and early steroid withdrawal; the other uses belatacept with mycophenolate and chronic steroids. Both are compared to past tacrolimus-based treatments.

What are the potential side effects?

Possible side effects include increased risk of infection, potential organ inflammation due to immune system suppression, digestive issues from mycophenolate mofetil, anemia or blood cell count changes from antithymocyte globulin, and wound healing complications.

Eligibility Criteria

Inclusion Criteria

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

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I am getting a kidney transplant from a living person or a recently deceased donor.

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I am getting a kidney transplant from a living or deceased donor with a functioning heart.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain transplant rejection drugs.

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I received a kidney transplant from a donor with a different blood type.

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I am on long-term steroid treatment at the time of my transplant.

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I do not have any infections or unstable conditions that could affect the study.

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I have not been exposed to the Epstein Barr Virus.

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I don't have hepatitis B, but my kidney donor does.

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I am scheduled for a dual or en bloc kidney transplant.

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I have low platelet, white blood cell counts, or very low hemoglobin levels.

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My organ transplant is expected to be preserved for more than 30 hours before transplantation.

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I am receiving a kidney from a donor who has hepatitis C.

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I am getting a transplant from a donor who is a perfect match.

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I can communicate and cooperate with the study team.

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My immune system reacts strongly to certain transplant markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite endpoint of patient death, graft loss, or eGFR (MDRD) < 45ml/min mL/min/1.73m2

Secondary study objectives

# Patients with Incidence of Infections

# Patients with development of de novo donor specific antibody (DSA)

# of Patients with eGFR (MDRD) < 30 mL/min/1.73m2

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group D Bela/EVRExperimental Treatment3 Interventions

rATG induction/belatacept/everolimus/early steroid withdrawal rATG 1.5mg/kg IV X 4 doses over 10 days belatacept 10mg/kg IV X 1 on POD 1, POD 5, weeks 2, 4, 8, and 12 then 5mg/kg IV X 1 on week 16 and then every 4 weeks thereafter Steroid taper x 5 days (500mg IV, 250mg IV, 125mg IV, 80mg po, 60mg po) Everolimus started within 24hours at 2mg BID and dosed to level 3-8ng/ml

Group II: Group E Bela/MMFActive Control4 Interventions

rATG induction/belatacept/mycophenolate/chronic steroidsrATG 1.5mg/kg IV X 4 doses over 10 days belatacept 10mg/kg IV X 1 on POD 1, POD 5, weeks 2, 4, 8, and 12 then 5mg/kg IV X 1 on week 16 and then every 4 weeks thereafter Steroid taper x 5 days (500mg IV, 250mg IV, 125mg IV, 80mg po, 60mg po) and then 5mg po daily thereafter MMF 1gm BID started pre-op and then continued throughout study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Antithymocyte immunoglobulin (rabbit)

FDA approved

Belatacept

FDA approved

0 / 15Eligibility criteria met