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Belatacept + Everolimus for Kidney Transplant Rejection (BETTER Trial)
BETTER Trial 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.
BETTER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBETTER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BETTER Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Group E Bela/MMF
- Group 2: Group D Bela/EVR
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- 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.
Frequently Asked Questions
What indications is Belatacept most frequently employed for?
"Belatacept is an effective treatment for a variety of conditions, including lung cancer and ulcerative colitis. It can also be used to treat more rare ailments such as varicella-zoster virus acute retinal necrosis and advanced carcinoid tumor."
What earlier investigations have been conducted on Belatacept?
"Currently, there exists 573 live clinical trials that are probing the efficacy of Belatacept; with 125 of those studies operating at Phase 3. Most investigative sites for this drug are located in Philadelphia, Pennsylvania, yet a total of 21225 global locations have active research projects associated with this medication."
What potential adverse effects may arise from the utilization of Belatacept?
"Our experts at Power have rated Belatacept with a score of 3 out the maximum score of three due to its approval from Phase 4 trials."
What is the current number of participants in this clinical experiment?
"Affirmative. Clinicaltrials.gov reports that this medical investigation, which was first advertised on April 9th 2021, is presently enrolling subjects. Approximately 120 people must be enrolled from 2 separate clinical sites."
Are any opportunities still available to join this clinical experiment?
"Indeed, clinicaltrials.gov confirms that this medical trial was first posted on April 9th 2021 and is actively recruiting participants. The study requires 120 people to be recruited from two separate sites."
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