Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

Status unconfirmed · Phase 4

Conditions studied: Kidney Transplant Rejection

In brief

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 regimen with rabbit antithymocyte globulin induction (rATG) and 2) a belatacept, mycophenolate, chronic steroid regimen with rATG and compare to historical controls of tacrolimus-based and belatacept-based regimens in combination with rATG induction, mycophenolate, and ESWD in renal transplant recipients. The purpose is to evaluate the effect of 2 regimens (rATG induction/belatacept/everolimus/ESWD and rATG induction/belatacept/mycophenolate/CS) on the composite of patient death, graft loss, or eGFR (MDRD) \< 45 mL/min/1.73m2 at Month 12 post-transplantation compared to historical controls of the BEST Trial (groups B and C).

Key facts

Study ID

NCT04849533

Run by

University of Cincinnati

People needed

120

Starts

2021-04-09

Expected to finish

2024-07-01

Last updated by the study team

2021-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.