Status:
UNKNOWN
Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)
Lead Sponsor:
University of Cincinnati
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to determine the safety and efficacy of two calcineurin inhibitor free treatment groups 1) a belatacept, everolimus and early corticosteroid withdrawal (ECSWD) immunosuppressive...
Detailed Description
The BETTER trial is designed to determine the safety and efficacy of two calcineurin inhibitor free treatment groups 1) a belatacept, everolimus and early corticosteroid withdrawal (ESWD) immunosuppre...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Male and female patients ≥ 18 years of age.
- Patient who is receiving a renal transplant from a living or heart-beating deceased donor.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
- The patient has given written informed consent to participate in the study
- Exclusion criteria
- Patient has previously received an organ transplant other than a kidney.
- Patient is receiving an HLA identical living donor transplant.
- Patient who is a recipient of a multiple organ transplant.
- Patient has a most recent cytotoxic PRA of \>25% or calculated PRA \>50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.
- Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.
- Patient with a donor specific antibody (DSA) as deemed by the PI to be associated with significant risk of rejection.
- Patient has received an ABO incompatible donor kidney.
- The deceased donor and/or deceased donor kidney meet any of the following extended criteria for organ donation (ECD):
- Donor age ≥ 60 years OR
- Donor age 50-59 years and 1 of the following:
- i. Cerebrovascular accident (CVA) + hypertension + SCr \> 1.5 mg/dL OR ii. CVA + hypertension OR iii. CVA + SCr \> 1.5 mg/dL OR iv. Hypertension + SCr \> 1.5 mg/dL OR c. CIT ≥ 24 hours, donor age \> 10 years OR d. Donation after cardiac death (DCD)
- Recipients will be receiving a dual or en bloc kidney transplant.
- Donor anticipated cold ischemia is \> 30 hours.
- Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C viral load are excluded. HCV seropositive patients with a negative HCV viral load testing may be included.
- Recipients receiving a kidney from a donor with HCV viremia (detected through nucleic acid testing or other means)
- Recipients with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.
- Hepatitis B surface antibody negative recipients receiving a kidney from a donor seropositive for hepatitis B core antibody or hepatitis B nucleic acid.
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- Recipient who is seronegative for Epstein Barr Virus (EBV)
- Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- Patients with thrombocytopenia (PLT \<75,000/mm3), and/or leukopenia (WBC \< 2,000/mm3), or anemia (hemoglobin \< 6 g/dL) prior to study inclusion.
- Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
- Patient who has undergone desensitization therapy within 6 months prior to transplant.
- Patient has a known hypersensitivity to belatacept, tacrolimus, mycophenolate mofetil/mycophenolic acid, everolimus, rabbit anti-thymocyte globulin, or glucocorticoids.
- Patient is receiving chronic steroid therapy at the time of transplant.
- Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years, unless they have an expected disease-free survival of \>95%.
- Patient is pregnant, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
- Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
- Inability to cooperate or communicate with the investigator.
Exclusion
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04849533
Start Date
April 9 2021
End Date
July 1 2024
Last Update
April 19 2021
Active Locations (2)
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1
The Christ Hospital
Cincinnati, Ohio, United States, 45219
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267