Belatacept Early Steroid Withdrawal Trial

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study purpose is to determine the safety and efficacy of a belatacept-based immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit antithymocyte globulin (rATG) induction and early glucocorticoid withdrawal (CSWD) and a belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant recipients.

The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab induction, mycophenolate mofetil (MMF)/mycophenolic acid (MPA), and early glucocorticoid withdrawal (Group A) in renal transplant recipients or Belatacept-based immunosuppressive regimen with rabbit antithymocyte globulin induction, MMF/MPA and early glucocorticoid withdrawal (Group B) will lead to less risk of graft loss, patient death, or reduced renal function at 12 months as compared to a tacrolimus-based immunosuppressive regimen with rabbit antithymocyte globulin, MMF/MPA, and early glucocorticoid withdrawal in renal transplant recipients (Group C).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Abatacept; Alemtuzumab; Antilymphocyte Serum; Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

1. Male and female patients > 18 years of age.

2. Patient who is receiving a renal transplant from a living or deceased donor.

3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.

4. The patient has given written informed consent to participate in the study.

Exclusion Criteria:

1. Patient has previously received an organ transplant other than a kidney.

2. Patient is receiving an human leucocyte antigen (HLA) identical living donor transplant.

3. Patient who is a recipient of a multiple organ transplant.

4. Patient has a most recent cytotoxic panel reactive antibody (PRA) of >25% or calculated PRA of > 50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.

5. Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.

6. Patient with a donor specific antibody (DSA) as deemed by the local PI to be associated with significant risk of rejection.

7. Patient has received a blood group (ABO) incompatible donor kidney.

8. The donor and/or 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:

• Cerebrovascular accident (CVA) + hypertension + serum creatinine (SCr) > 1.5 mg/dL OR

• CVA + hypertension OR

• CVA + SCr > 1.5 mg/dL OR

• Hypertension + SCr > 1.5 mg/dL OR

• Cold ischemia time (CIT) > 24 hours, donor age > 10 years OR

• Donation after cardiac death (DCD)

9. Recipients will be receiving a dual or en bloc kidney transplant.

10. Donor anticipated cold ischemia is > 30 hours.

11. 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.

12. Recipients who are Hepatitis B core antibody seropositive are eligible if their hepatitis B viral loads are negative. After transplant, their hepatitis B viral loads will be monitored every three months for the first year after transplant. If hepatitis B viral loads become positive, patients will be treated per institutional standard of care.

13. Patients who are Hepatitis B surface antibody seropositive and who receive a kidney from a Hepatitis B core surface antibody positive donor may be included.

14. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).

15. Recipient who is seronegative for Epstein Barr virus (EBV).

16. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.

17. Patients with thrombocytopenia (PLT < 75,000/mm3), and/or leucopoenia (WBC < 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.

18. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.

19. Patient who has undergone desensitization therapy within 6 months prior to transplant.

20. Patient has a known hypersensitivity to belatacept, tacrolimus, mycophenolate mofetil, alemtuzumab, rabbit anti-thymocyte globulin, or glucocorticoids.

21. Patient is receiving chronic steroid therapy at the time of transplant.

22. 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%.

23. 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.

24. Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.

25. 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.

26. Inability to cooperate or communicate with the investigator.