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Efficacy of Belatacept in Reducing DSA

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02078193
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : July 6, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Bolin, East Carolina University

Brief Summary:
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Belatacept Phase 4

Detailed Description:
The aim of this study is to evaluate patients converted to belatacept in combination with Mycophenolate Mofetil (MMF) with corticosteroids with respect to their DSA titer. Patients in this study will be converted from their calcineurin inhibitor (CNI) to belatacept from baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be calculated per prescribing information for dosing maintenance phase (5mg per kg every 28 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory, Open-label, Single Center Study to Assess the Efficacy of NULOJIX (Belatacept) in Reducing Donor Specific Human Leukocyte Antigen (HLA) Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients
Study Start Date : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: Belatacept
Participants will be converted from their current MMF to once a month infusions of Belatacept
Drug: Belatacept
Patients will be converted from their MMF to Belatacept




Primary Outcome Measures :
  1. Change of Donor Specific Antibodies (DSA) [ Time Frame: one year ]
    DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.


Secondary Outcome Measures :
  1. Safety [ Time Frame: one year ]
    Incidence of infections


Other Outcome Measures:
  1. Number of Participants With Chronic Kidney Rejection [ Time Frame: One year ]
    Incidence of chronic kidney rejection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recipients of cadaveric, living related or living unrelated kidney transplant with positive DSA titer (two positive tests) and enrolled within 6 months of DSA detection.
  • Patients with stable renal function. Stable renal function is defined as one serum creatinine (SCr) value that is +/- 10% of the baseline SCr within 3 months of enrollment (eGFR >/= 35 and </= 75 mL/min/1.73m^2).
  • Patients who are EBV seropositive
  • Males and females, 18-75 years of age;
  • Patients currently receiving mycophenolic acid (MPA) (CellCept daily or myfortic daily), cyclosporine or tacrolimus with corticosteroids as part of their immunosuppressive regimen
  • Patients willing to be converted to belatacept from cyclosporine or tacrolimus.
  • Females of childbearing potential must have a negative pregnancy test prior to enrollment. The test should be performed at baseline visit. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication;
  • Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria:

  • Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet, bone marrow), either concurrent or previous (with exception that a second kidney transplant is allowed);
  • Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit;
  • Patients who have received any investigational drug within 4 weeks prior to study entry;
  • Patients with HLA identical
  • Patients who are Epstein-Barr virus (EBV) seronegative
  • Presence of clinically significant infection requiring continued therapy, chronic infection (e.g. HIV, Hep B and Hep C), malignancy (within last 5 years, except excised squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity that would interfere with the appropriate conduct of the study;
  • Evidence of severe liver disease (incl. abnormal liver profile i.e. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or total bilirubin >/= 3 times ULN) or severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study;
  • Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study;
  • Patients with symptoms of significant somatic or mental illness or evidence of drug and/or alcohol abuse;
  • Patients receiving > 10 mg/day prednisone dose;
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures to belatacept;
  • Patients not making DSA antibodies;
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (local); females of childbearing potential who are unwilling to use effective study-approved contraceptives and who are planning to become pregnant; Sexually active fertile men must use effective birth control if their partners are women of child bearing potential;
  • Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study, including but not limited to visual problems or cognitive impairment.

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): NCT02078193


Locations
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United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Investigators
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Principal Investigator: Paul Bolin, MD East Carolina University, Department Chair of Internal Medicine
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Responsible Party: Paul Bolin, Dr. Paul Bolin, MD, East Carolina University
ClinicalTrials.gov Identifier: NCT02078193    
Other Study ID Numbers: IM103-302
First Posted: March 5, 2014    Key Record Dates
Results First Posted: July 6, 2017
Last Update Posted: August 1, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents