Veloxis de Novo Kidney Transplant ECSWD

Sponsor
Simon Tremblay, PharmD, PhD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03828682
Collaborator
Veloxis Pharmaceuticals (Industry)
60
2
2
36.3
30
0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controlsA prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controls
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients
Actual Study Start Date :
Jun 21, 2019
Anticipated Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prospective Arm

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]
Tacrolimus Extended Release Oral Tablet [Envarsus]
Other Names:
  • Envarsus XR
  • Drug: Mycophenolate Mofetil
    Mycophenolate mofetil capsules or tablets
    Other Names:
  • Cellcept
  • MMF
  • Drug: Mycophenolic Acid Oral Product
    mycophenolic acid tablets
    Other Names:
  • Myfortic
  • MPA
  • Drug: Methylprednisolone
    Methylprednisolone taper

    Drug: Prednisone
    Prednisone taper
    Other Names:
  • Deltasone
  • Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
    Rabbit Anti-Human T-Lymphocyte Globulin
    Other Names:
  • Thymoglobulin
  • rATG
  • Active Comparator: Comparator arm

    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
    Mycophenolate mofetil capsules or tablets
    Other Names:
  • Cellcept
  • MMF
  • Drug: Mycophenolic Acid Oral Product
    mycophenolic acid tablets
    Other Names:
  • Myfortic
  • MPA
  • Drug: Tacrolimus
    Twice daily tacrolimus
    Other Names:
  • Prograf
  • FK506
  • Drug: Methylprednisolone
    Methylprednisolone taper

    Drug: Prednisone
    Prednisone taper
    Other Names:
  • Deltasone
  • Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
    Rabbit Anti-Human T-Lymphocyte Globulin
    Other Names:
  • Thymoglobulin
  • rATG
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss [12 months]

      Biopsy-proven acute rejection, patient death and graft loss

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male and female patients ≥ 18 years of age.

    2. Patient who is receiving a renal transplant from a living or heart-beating 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 HLA identical living donor transplant.

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

    4. 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.

    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 PI to be associated with significant risk of rejection.

    7. Patient has received an ABO incompatible donor kidney.

    8. The deceased donor and/or deceased donor kidney meet any of the following extended criteria for organ donation (ECD):

    9. Donor age ≥ 60 years OR

    10. Donor age 50-59 years and 1 of the following:

    1. 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)
    1. Recipients will be receiving a dual or en bloc kidney transplant.

    2. Donor anticipated cold ischemia is >30hours.

    3. 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.

    4. Recipients with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.

    5. Hepatitis B surface antibody negative recipients receiving a kidney from a donor seropositive for hepatitis B core antibody or hepatitis B nucleic acid.

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

    7. Recipient who is seronegative for Epstein Barr Virus (EBV)

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

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

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

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

    12. Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil/mycophenolic acid, rabbit anti-thymocyte globulin, or glucocorticoids.

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

    14. 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%.

    15. 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.

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

    17. 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.

    18. Inability to cooperate or communicate with the investigator.

    19. Renal allograft has been reperfused for more than 48 hours at the time of enrollment

    20. Patient unable to receive intact LCPT formulation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Christ Hospital Cincinnati Ohio United States 45219
    2 University of Cincinnati Cincinnati Ohio United States 45267

    Sponsors and Collaborators

    • Simon Tremblay, PharmD, PhD
    • Veloxis Pharmaceuticals

    Investigators

    • Principal Investigator: Simon Tremblay, PharmD, PhD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Simon Tremblay, PharmD, PhD, Research Assistant Professor of Surgery, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT03828682
    Other Study ID Numbers:
    • 2018-7742
    First Posted:
    Feb 4, 2019
    Last Update Posted:
    May 13, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Simon Tremblay, PharmD, PhD, Research Assistant Professor of Surgery, University of Cincinnati
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2020