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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
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 belowSelect...
I am getting a kidney transplant from a living person or a recently deceased donor.
Select...
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:Select...
I am allergic to certain transplant rejection drugs.
Select...
I received a kidney transplant from a donor with a different blood type.
Select...
I am on long-term steroid treatment at the time of my transplant.
Select...
I do not have any infections or unstable conditions that could affect the study.
Select...
I have not been exposed to the Epstein Barr Virus.
Select...
I don't have hepatitis B, but my kidney donor does.
Select...
I am scheduled for a dual or en bloc kidney transplant.
Select...
I have low platelet, white blood cell counts, or very low hemoglobin levels.
Select...
My organ transplant is expected to be preserved for more than 30 hours before transplantation.
Select...
I am receiving a kidney from a donor who has hepatitis C.
Select...
I am getting a transplant from a donor who is a perfect match.
Select...
I can communicate and cooperate with the study team.
Select...
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
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 moreTrial 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
Antithymocyte immunoglobulin (rabbit)
FDA approved
Everolimus
FDA approved
Belatacept
FDA approved
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
433 Previous Clinical Trials
636,283 Total Patients Enrolled
Rita R Alloway, PharmDPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to certain transplant rejection drugs.The kidney I may receive is from a donor who meets specific health criteria.I received a kidney transplant from a donor with a different blood type.I underwent desensitization therapy within the last 6 months before my transplant.I am on long-term steroid treatment at the time of my transplant.I haven't had cancer, except for non-melanoma skin cancer, in the last 5 years or my doctor expects me to be cancer-free.I do not have any infections or unstable conditions that could affect the study.I am a woman who can have children and have a recent negative pregnancy test.I have not been exposed to the Epstein Barr Virus.I am getting a kidney transplant from a living person or a recently deceased donor.I do not have an active hepatitis C infection.I don't have hepatitis B, but my kidney donor does.I am scheduled for a dual or en bloc kidney transplant.I have low platelet, white blood cell counts, or very low hemoglobin levels.My organ transplant is expected to be preserved for more than 30 hours before transplantation.I am using reliable birth control or have had surgery to prevent pregnancy.I am getting a kidney transplant from a living or deceased donor with a functioning heart.I am 18 years old or older.I am 18 years old or older.I am a woman who can have children and have a recent negative pregnancy test.I have tested positive for hepatitis B in the last year.I am receiving a kidney from a donor who has hepatitis C.I am getting a transplant from a donor who is a perfect match.I can communicate and cooperate with the study team.My immune system reacts strongly to certain transplant markers.
Research Study Groups:
This trial has the following groups:- Group 1: Group E Bela/MMF
- Group 2: Group D Bela/EVR
Awards:
This trial has 5 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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