Veloxis de Novo Kidney Transplant ECSWD

Status unconfirmed · Phase 4

Conditions studied: Kidney Transplantation, Immunosuppression

In brief

This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.

Key facts

Study ID

NCT03828682

Run by

Simon Tremblay, PharmD, PhD

People needed

60

Starts

2019-06-21

Expected to finish

2022-06-30

Last updated by the study team

2020-05-13

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 >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%.

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

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