Veloxis de Novo Kidney Transplant ECSWD | NCT03828682

Status Module

Name	Class
Veloxis Pharmaceuticals	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective Arm	Experimental	De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery	Drug: Tacrolimus Extended Release Oral Tablet [Envarsus] Drug: Mycophenolate Mofetil Drug: Mycophenolic Acid Oral Product Drug: Methylprednisolone Drug: Prednisone Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
Comparator arm	Active Comparator	Historical control arm consisting of the following De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery	Drug: Mycophenolate Mofetil Drug: Mycophenolic Acid Oral Product Drug: Tacrolimus Drug: Methylprednisolone Drug: Prednisone Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus Extended Release Oral Tablet [Envarsus]	Drug	Tacrolimus Extended Release Oral Tablet [Envarsus]	Prospective Arm

Measure	Description	Time Frame
Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss	Biopsy-proven acute rejection, patient death and graft loss	12 months

Eligibility Module

Eligibility Criteria

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):
1. Donor age ≥ 60 years OR
2. 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 >30hours.
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 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 tacrolimus, mycophenolate mofetil/mycophenolic acid, 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.
Renal allograft has been reperfused for more than 48 hours at the time of enrollment
Patient unable to receive intact LCPT formulation

ID	Term
D016559	Tacrolimus
D009173	Mycophenolic Acid
D008775	Methylprednisolone
D011241	Prednisone
C512542	thymoglobulin

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols