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Belatacept for Renal Transplant Recipients With Delayed Graft Function

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ClinicalTrials.gov Identifier: NCT02134288
Recruitment Status : Unknown
Verified January 2017 by Von Visger, Jon, MD, Ohio State University.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Von Visger, Jon, MD, Ohio State University

Brief Summary:
Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Belatacept Drug: Everolimus Early Phase 1

Detailed Description:
Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
Study Start Date : April 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Belatacept
Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study.
Drug: Belatacept
Other Name: NULOJIX

Active Comparator: Everolimus
Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.
Drug: Everolimus
Other Name: zortress




Primary Outcome Measures :
  1. Time to recover from Delayed Graft Function [ Time Frame: 2 weeks ]
    For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks).


Secondary Outcome Measures :
  1. Percent patients reaching recovery (defined above) by 14 days and 3 months. [ Time Frame: Assessed at 3, 6, 12 months ]
    Percent patients reaching recovery (defined above) by 14 days and 3 months.

  2. Hospital length of stay (days) from date of transplant to discharge [ Time Frame: up to 7 days ]
    by monitoring patient while inpatient

  3. Number of dialysis treatments [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's

  4. Number of biopsies [ Time Frame: Assessed at 3, 6, 12 months ]
    medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period

  5. Biopsy proven acute rejection events [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's

  6. Patient and graft survival [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's

  7. Number of hospital readmissions [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's

  8. Detection of DSA (Luminex) [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draw

  9. Incidence and type of infection [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's

  10. Measured or estimated creatinine clearance. [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draw

  11. Banff score of rejection episodes and immune suppression treatment/management of rejection [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's

  12. Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored). [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Written Informed Consent
  2. Deceased donor renal transplant recipient
  3. Men and women, aged 18-60 years of age

Exclusion Criteria:

  1. Seronegative or unknown EBV serostatus
  2. Patients unwilling or incapable of providing informed consent.
  3. Patients with active tuberculosis or positive TB test without evidence of infection treatment.
  4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
  5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
  6. Inadequate vein access to receive monthly IV infusions
  7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
  8. Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
  9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol.
  10. Prisoners or subjects who are involuntarily incarcerated.
  11. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II

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): NCT02134288


Contacts
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Contact: Brittany Holloway 614-293-4665 brittany.holloway@osumc.edu

Locations
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United States, Ohio
The Ohio State Universtiy Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43212
Contact: Margaret Wuebker    614-293-4665    margaret.wuebker@osumc.edu   
Principal Investigator: Jon Von Visger, M.D./Ph.D.         
Sponsors and Collaborators
Von Visger, Jon, MD
Bristol-Myers Squibb
Investigators
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Principal Investigator: Jon Von Visger, M.D./Ph.D. OSU Wexner Medical Center
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Responsible Party: Von Visger, Jon, MD, Assistant Professor of Internal Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT02134288    
Other Study ID Numbers: IM103-336
2013H0312 ( Other Identifier: The Ohio State University Wexner Medical Center )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Von Visger, Jon, MD, Ohio State University:
Dialysis
Kidney Transplant
immunosuppressive therapy
Delayed Graft Function
Belatacept
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes
Everolimus
Abatacept
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents