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Veloxis de Novo Kidney Transplant ECSWD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828682
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
Simon Tremblay, PharmD, PhD, University of Cincinnati

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
Kidney Transplantation Immunosuppression Drug: Tacrolimus Extended Release Oral Tablet [Envarsus] Drug: Mycophenolate Mofetil Drug: Mycophenolic Acid Oral Product Drug: Tacrolimus Drug: Methylprednisolone Drug: Prednisone Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : June 21, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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 Name: 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 Name: 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 Name: Deltasone

Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
Rabbit Anti-Human T-Lymphocyte Globulin
Other Names:
  • Thymoglobulin
  • rATG




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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):

    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)

  9. Recipients will be receiving a dual or en bloc kidney transplant.
  10. Donor anticipated cold ischemia is >30hours.
  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 with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.
  13. Hepatitis B surface antibody negative recipients receiving a kidney from a donor seropositive for hepatitis B core antibody or hepatitis B nucleic acid.
  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 leukopenia (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 tacrolimus, mycophenolate mofetil/mycophenolic acid, 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.
  27. Renal allograft has been reperfused for more than 48 hours at the time of enrollment
  28. Patient unable to receive intact LCPT formulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828682


Contacts
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Contact: Simon Tremblay, PharmD, PhD 513-558-9967 tremblsn@ucmail.uc.edu

Locations
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United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Simon Tremblay, PharmD, PhD    513-558-9967    simon.tremblay@uc.edu   
Sub-Investigator: Adele Rike-Shields, PharmD         
Sub-Investigator: Ervin S Woodle, MD         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Simon Tremblay, PharmD, PhD    513-558-9967    simon.tremblay@uc.edu   
Sub-Investigator: Rita R Alloway, PharmD         
Sub-Investigator: Ervin S Woodle, MD         
Sub-Investigator: Amit Govil, MD         
Sponsors and Collaborators
Simon Tremblay, PharmD, PhD
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Simon Tremblay, PharmD, PhD University of Cincinnati
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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: February 4, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Cincinnati:
tacrolimus
extended release
kidney transplantation
steroid withdrawal
once daily
Additional relevant MeSH terms:
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Mycophenolic Acid
Prednisone
Methylprednisolone
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents