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Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

This study has been terminated.
(Safety: Stopping rule not met.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01856257
First Posted: May 17, 2013
Last Update Posted: August 7, 2017
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.
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.

Condition Intervention Phase
Primary Renal Allograft Candidate Kidney Transplantation Biological: Anti-thymocyte Globulin (Rabbit) Biological: belatacept Drug: methylprednisolone Biological: basiliximab Drug: mycophenolate mofetil Drug: tacrolimus Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Steroid and Tacrolimus Avoidance Using NULOJIX® (Belatacept) in Renal Transplantation (CTOT-16)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):

    • A score of ≥90 means kidney function is normal.
    • A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
    • Scores between 30 and 59 indicates moderately reduced kidney function.
    • Scores between 15 and 29 indicate severely reduced kidney function.
    • Scores below 15 indicate very severe or end stage kidney failure.


Secondary Outcome Measures:
  • Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.

  • Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):

    • A score of ≥90 means kidney function is normal.
    • A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
    • Scores between 30 and 59 indicates moderately reduced kidney function.
    • Scores between 15 and 29 indicate severely reduced kidney function.
    • Scores below 15 indicate very severe or end stage kidney failure.

  • Count of Participants by CKD Stage at Wk 52 [ Time Frame: Week 52 ]

    The stages of Chronic Kidney Disease are defined using the participant's GFR value:

    • Stage 1 if GFR value is ≥90 ( kidney function is normal)
    • Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)
    • Stage 3A if 45 ≤ GFR < 60*
    • Stage 3B if 30 ≤ GFR < 45*
    • Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)
    • Stage 5 if GFR < 15 (severe or end stage kidney failure).

    Stages 3A and 3B indicate moderately reduced kidney function.*


  • Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value:

    • Stage 1 if GFR value is ≥ 90 (kidney function is normal)
    • Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)
    • Stage 3A if 45 <= GFR < 60*
    • Stage 3B if 30 <= GFR < 45*
    • Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)
    • Stage 5 if GFR < 15 (severe or end stage kidney failure).

    Stages 3A abd 3B indicate moderately reduced kidney function.*


  • Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):

    • A score of ≥ 90 means kidney function is normal.
    • A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
    • Scores between 30 and 59 indicates moderately reduced kidney function.
    • Scores between 15 and 29 indicate severely reduced kidney function.
    • Scores below 15 indicate severe or endstage kidney failure.

  • The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant [ Time Frame: Day 28 through Week 52 Post-Transplant ]

    The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):

    • A score of ≥ 90 means kidney function is normal.
    • A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.
    • Scores between 30 and 59 indicates moderately reduced kidney function.
    • Scores between 15 and 29 indicate severely reduced kidney function.
    • Scores below 15 indicate very severe or endstage kidney failure.

    An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.

    Larger numbers indicate greater change in kidney function.


  • Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.

  • Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.

  • Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade.

  • Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.

  • Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies [ Time Frame: Transplantation through Week 52 ]

    Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows:

    • ACR= Acute T-Cell Mediated rejection
    • AMR= Acute Antibody-mediated rejection
    • Chr. AMR=Chronic Antibody Mediated Rejection
    • Gd.=Grade
    • IFTA=Interstitial Fibrosis and Tubular Atrophy

  • Type of Treatment for Detected Graft Rejection [ Time Frame: Transplantation through Week 52 ]

    Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below.

    ATG=Thymoglobulin


  • Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft.

    No data available.


  • Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO [ Time Frame: Transplantation through Week 52 ]

    New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.

    Acronyms: American Diabetes Association (ADA); World Health Organization (WHO).


  • Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant [ Time Frame: Day 14 through week 52 ]
    Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.

  • Hemoglobin A1c (HbA1c) Measurements Over Time [ Time Frame: Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant ]

    Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:

    • A value below 6.0% reflects normal levels,
    • 6.0% to 6.4% reflects prediabetes, and
    • a value of ≥ 6.5% reflects diabetes.

  • Standardized Blood Pressure Measurement at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.

    • Systolic measures of <120 and diastolic measures of <80 are considered normal.
    • Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).
    • Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.

  • Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant [ Time Frame: Week 52 ]
    Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction.

  • Fasting Lipid Profile at Baseline (Pre-Transplant) [ Time Frame: Baseline ]

    A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:

    • Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
    • LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
    • HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
    • Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and
    • Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.

  • Fasting Lipid Profile at Wk 28 Post-Transplant [ Time Frame: Week 28 ]

    A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:

    • Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
    • LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
    • HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
    • Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and
    • Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.

  • Fasting Lipid Profile at Wk 52 Post-Transplant [ Time Frame: Week 52 ]

    A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:

    • Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease
    • LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease
    • HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease
    • Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and
    • Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.

  • Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant [ Time Frame: Baseline (Pre-Transplant), Week 28, and Week 52 ]
    Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.

  • Total Daily Prescribed Pill Count [ Time Frame: Day 28, Day 84, Week 28, Week 36, and Week 52 ]
    This is a measure of the total number of pills a participant was prescribed on a given day

  • Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.

  • Count of Participants With Graft Rejection by Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.

  • Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 [ Time Frame: Enrollment through Week 52 ]
    Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.

  • Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.

  • Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant [ Time Frame: Transplantation through Week 52 ]
    Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.

  • Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events [ Time Frame: Transplantation through Week 52 ]
    Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.

  • Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure [ Time Frame: Within 24 Hours of transplant procedure ]
    Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.


Enrollment: 71
Study Start Date: July 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thymoglobulin®+tacrolimus+MMF
Induction with Thymoglobulin®, methylprednisolone, and maintenance immunosuppression with tacrolimus and mycophenolate mofetil (MMF)
Biological: Anti-thymocyte Globulin (Rabbit)
The target dosage is 6mg/kg total over 3 to 4 days. The recommended route of administration is intravenous infusion using a high-flow vein.
Other Names:
  • Thymoglobulin®
  • ATG (Rabbit)
Drug: methylprednisolone
Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.
Other Name: Medrol®
Drug: mycophenolate mofetil
Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
Other Names:
  • MMF
  • CellCept®
  • mycophenolate acid
Drug: tacrolimus
The site investigator will identify a starting tacrolimus dose at their discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. The dose will be adjusted to 5-8ng/ml for the active comparator arm (thymoglobulin + tacrolimus + MMF arm) or tapered off in the experimental arm (basiliximab + 20 weeks of tacrolimus + MMF + belatacept).
Other Name: Prograf®
Experimental: Thymoglobulin®+belatacept+MMF
Induction with Thymoglobulin®, methylprednisolone, and maintenance with belatacept and mycophenolate mofetil (MMF)
Biological: Anti-thymocyte Globulin (Rabbit)
The target dosage is 6mg/kg total over 3 to 4 days. The recommended route of administration is intravenous infusion using a high-flow vein.
Other Names:
  • Thymoglobulin®
  • ATG (Rabbit)
Biological: belatacept
Participants will receive belatacept at a dose of 10mg/kg up on day 1, 5, 14, 28, 56 and 84. After 84 days, subjects will receive a maintenance dose of 5 mg/kg every 4 weeks until completion of the trial.
Other Name: NULOJIX®
Drug: methylprednisolone
Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.
Other Name: Medrol®
Drug: mycophenolate mofetil
Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
Other Names:
  • MMF
  • CellCept®
  • mycophenolate acid
Experimental: Basiliximab+20 weeks of tacrolimus+MMF + belatacept

Induction basiliximab and methylprednisolone, administration of NULOJIX® (belatacept) 24 hours post reperfusion (+/-12 hrs); maintenance immunosuppression with 1. )20 week course of Prograf® (tacrolimus) or equivalent 2.) CellCept® (mycophenolate mofetil- MMF), or Myfortic® (mycophenolate sodium), or equivalent.

Subjects participating in this arm may have tacrolimus reinstated, at a dose to be determined by the site investigator, if any of the following events occur: 1 - An acute rejection episode 2- Request of the subject or site Investigator.

Biological: belatacept
Participants will receive belatacept at a dose of 10mg/kg up on day 1, 5, 14, 28, 56 and 84. After 84 days, subjects will receive a maintenance dose of 5 mg/kg every 4 weeks until completion of the trial.
Other Name: NULOJIX®
Drug: methylprednisolone
Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.
Other Name: Medrol®
Biological: basiliximab
Basiliximab will be administered in two doses of 20 mg each.
Other Name: Simulect®
Drug: mycophenolate mofetil
Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
Other Names:
  • MMF
  • CellCept®
  • mycophenolate acid
Drug: tacrolimus
The site investigator will identify a starting tacrolimus dose at their discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. The dose will be adjusted to 5-8ng/ml for the active comparator arm (thymoglobulin + tacrolimus + MMF arm) or tapered off in the experimental arm (basiliximab + 20 weeks of tacrolimus + MMF + belatacept).
Other Name: Prograf®

Detailed Description:

Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system against illness) from rejecting their new kidney. Most patients who receive a kidney transplant must take these anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work.

The purpose of this study is to determine if NULOJIX® (belatacept), will minimize serious long term side effects seen with anti-rejection medications while still protecting the transplanted kidney from damage. The researchers also want to learn more about the safety of this treatment and the long term health of the transplanted kidney.

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female, 18-65 years of age at the time of enrollment;
  • Ability to understand and provide written informed consent;
  • Candidate for primary renal allograft from either living or deceased donor;
  • No known contraindications to study therapy using NULOJIX® (belatacept);
  • Female participants of childbearing potential must have a negative pregnancy test upon study entry;
  • Participants with reproductive potential must agree to use an appropriate method(s) of birth control as outlined in the CellCept® , Myfortic® or generic package labeling during participation in the study and for 4 months following completion of the study;
  • No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator;
  • Negative crossmatch or Panel Reactive Antibodies (PRA) of 0% on historic and current sera, as determined by each participating study center;
  • A documented negative tuberculosis (TB) test within the 6 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed.

Exclusion Criteria:

  • Need for multi-organ transplant;
  • Recipient of previous organ transplant;
  • Epstein-Barr Virus (EBV) seronegative (or unknown) recipients;
  • Active infection including hepatitis B, hepatitis C, or human Immunodeficiency Virus (HIV);
  • Individuals who have required treatment with prednisone or other immunosuppressive drugs within 1 year prior to transplant;
  • Individuals undergoing transplant using organs from extended criteria donor (ECD) or donation after cardiac death (DCD) donors;
  • Histocompatibility antigen (HLA) identical living donors;
  • Individuals at significant risk of early recurrence of the primary renal disease including focal segmental glomerulosclerosis (FSGS) and membranoproliferative glomerulonephritis (MPGN) type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function;
  • Known history of thrombotic events or risk factors, including any of the following:

    • Factor V Leiden, elevated homocysteine, positive lupus anticoagulant, elevated anticardiolipin antibody, heparin-induced thrombocytopenia,
    • A family history of a heritable thrombotic condition,
    • Recurrent deep vein thrombosis (DVT) or pulmonary emboli (PE),
    • Unexplained stillborn infant or recurrent spontaneous abortion or other congenital or acquired thrombotic disorder.

At the discretion of the investigator, a history of thrombosis of a dialysis access graft, fistula, or indwelling catheter/device may not be considered an exclusion criterion.

  • Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
  • Use of investigational drugs within 4 weeks of enrollment;
  • Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;
  • Administration of live attenuated vaccine(s) within 8 weeks of enrollment;
  • Blood type A2 and A2B donors into blood type B recipients.
  Contacts and Locations
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): NCT01856257


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Investigators
Principal Investigator: Kenneth Newell, MD, PhD Emory University
Study Chair: Roslyn B. Mannon, M.D. University of Alabama at Birmingham
  More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01856257     History of Changes
Other Study ID Numbers: DAIT CTOT-16
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: June 23, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: July 2017

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Transplantation
Transplantation
NULOJIX
belatacept
chronic immunosuppression

Additional relevant MeSH terms:
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Basiliximab
Abatacept
Mycophenolic Acid
Antibodies, Monoclonal
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents