Primary Renal Allograft Candidate, Kidney Transplantation
Conditions
Keywords
Kidney Transplantation, Transplantation, NULOJIX, belatacept, chronic immunosuppression
Brief summary
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.
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.
Interventions
BIOLOGICALAnti-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.
BIOLOGICALbelatacept
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.
DRUGmethylprednisolone
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.
BIOLOGICALbasiliximab
Basiliximab will be administered in two doses of 20 mg each.
DRUGmycophenolate 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.
DRUGtacrolimus
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).
Sponsors
Clinical Trials in Organ Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant | 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
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant | Transplantation through Week 52 | Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist. |
| Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Hemoglobin A1c (HbA1c) Measurements Over Time | 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. |
Countries
United States
Participant flow
Recruitment details
Three sites in the United States recruited and enrolled 71 participants into this trial.
Participants by arm
| Arm | Count |
|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter. | 29 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:
Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.
Maintenance:
Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. | 29 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Induction:
Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.
Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.
The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.
Maintenance:
Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.
Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84 | 11 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 0 | 0 |
| Overall Study | Donor complication | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 11 Participants | 69 Participants |
| Age, Continuous | 47.7 years STANDARD_DEVIATION 6.76 | 44.5 years STANDARD_DEVIATION 10.45 | 44.6 years STANDARD_DEVIATION 9.63 | 45.9 years STANDARD_DEVIATION 8.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 25 Participants | 9 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 13 Participants | 5 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 4 Participants | 24 Participants |
| Region of Enrollment United States | 29 participants | 29 participants | 11 participants | 69 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 7 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 29 | 0 / 29 | 0 / 11 | 0 / 2 |
| other Total, other adverse events | 15 / 29 | 24 / 29 | 7 / 11 | 0 / 2 |
| serious Total, serious adverse events | 19 / 29 | 21 / 29 | 6 / 11 | 0 / 2 |
Outcome results
Primary
Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: Intent-to-treat population with available data at week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant | 59.2 mL/min/1.73m^2 | Standard Deviation 19.9 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant | 61.5 mL/min/1.73m^2 | Standard Deviation 23.3 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant | 63.0 mL/min/1.73m^2 | Standard Deviation 17.4 |
p-value: 0.54495% CI: [-7.999, 15.024]Mixed Models Analysis
p-value: 0.53195% CI: [-10.481, 20.121]Mixed Models Analysis
Secondary
Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant
This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant | 2 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant | 0 Participants |
Secondary
Count of Participants by CKD Stage at Wk 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.\*
Time frame: Week 52
Population: Intent-to-treat population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by CKD Stage at Wk 52 | Stage 5 | 3 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by CKD Stage at Wk 52 | Stage 1 | 3 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by CKD Stage at Wk 52 | Stage 3A | 11 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by CKD Stage at Wk 52 | Stage 4 | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by CKD Stage at Wk 52 | Stage 2 | 5 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by CKD Stage at Wk 52 | Stage 3B | 6 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 2 | 11 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 4 | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 5 | 3 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 3B | 2 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 3A | 9 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 1 | 3 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 5 | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 1 | 1 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 2 | 4 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 3A | 6 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 4 | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by CKD Stage at Wk 52 | Stage 3B | 0 Participants |
Secondary
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IIB | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IIA | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IA | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IB | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | III | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IIA | 4 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IA | 3 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IB | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IIB | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | III | 2 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | III | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IIB | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IA | 2 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IIA | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant | IB | 2 Participants |
Secondary
Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 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.
Time frame: Enrollment through Week 52
Population: Intent-to-treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 | Adverse Events | 21 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 | Serious Adverse Events | 19 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 | Adverse Events | 28 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 | Serious Adverse Events | 21 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 | Adverse Events | 9 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 | Serious Adverse Events | 6 Participants |
Secondary
Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant | 10 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant | 4 Participants |
Secondary
Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant | 1 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant | 0 Participants |
Secondary
Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant
Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant | 10 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant | 4 Participants |
Secondary
Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant | BKV | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant | CMV | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant | BKV | 4 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant | CMV | 6 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant | BKV | 1 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant | CMV | 1 Participants |
Secondary
Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant
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.\*
Time frame: Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant | 4 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant | 4 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant | 0 Participants |
Secondary
Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant | 6 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant | 9 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant | 0 Participants |
Secondary
Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.
Secondary
Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant | 21 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant | 15 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant | 6 Participants |
Secondary
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
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).
Time frame: Transplantation through Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | 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 | New onset diabetes during first 52 weeks | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | 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 | Impaired fasting glucose at week 52 | 2 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | 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 | New onset diabetes during first 52 weeks | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | 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 | Impaired fasting glucose at week 52 | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | 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 | New onset diabetes during first 52 weeks | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | 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 | Impaired fasting glucose at week 52 | 0 Participants |
Secondary
Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events | 0 Participants |
Secondary
Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset 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.
Time frame: Within 24 Hours of transplant procedure
Population: Intent-to-treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure | Fever >39 Celsius | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure | Systolic BP < 90 mmHg | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure | Fever >39 Celsius | 0 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure | Systolic BP < 90 mmHg | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure | Fever >39 Celsius | 0 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure | Systolic BP < 90 mmHg | 0 Participants |
Secondary
Count of Participants With Graft Rejection by Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Graft Rejection by Wk 52 Post-Transplant | 7 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Graft Rejection by Wk 52 Post-Transplant | 14 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Graft Rejection by Wk 52 Post-Transplant | 4 Participants |
Secondary
Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant
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.
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant | 1 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant | 8 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant | 2 Participants |
Secondary
Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant
Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for \>14 days.
Time frame: Day 14 through week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant | 3 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant | 2 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant | 0 Participants |
Secondary
Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant | 18 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant | 23 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant | 8 Participants |
Secondary
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant
Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.
Time frame: Baseline (Pre-Transplant), Week 28, and Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Week 28 | 8 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Baseline | 13 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Week 52 | 9 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Week 28 | 9 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Baseline | 7 Participants |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Week 52 | 9 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Baseline | 3 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Week 52 | 5 Participants |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant | Week 28 | 4 Participants |
Secondary
Fasting Lipid Profile at Baseline (Pre-Transplant)
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.
Time frame: Baseline
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Baseline (Pre-Transplant) | HDL | 45.1 mg/dL | Standard Deviation 11.8 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Baseline (Pre-Transplant) | LDL | 91.1 mg/dL | Standard Deviation 28 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Baseline (Pre-Transplant) | Total cholesterol | 167.1 mg/dL | Standard Deviation 37.5 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Baseline (Pre-Transplant) | Non-HDL | 122.0 mg/dL | Standard Deviation 35.1 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Baseline (Pre-Transplant) | Triglyceride | 156.8 mg/dL | Standard Deviation 103.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | LDL | 83.1 mg/dL | Standard Deviation 38.5 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | Total cholesterol | 159.4 mg/dL | Standard Deviation 45 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | Non-HDL | 116.1 mg/dL | Standard Deviation 45.7 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | HDL | 43.3 mg/dL | Standard Deviation 13 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | Triglyceride | 194.4 mg/dL | Standard Deviation 171.1 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | Triglyceride | 227.1 mg/dL | Standard Deviation 248.1 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | HDL | 44.1 mg/dL | Standard Deviation 19.9 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | Total cholesterol | 167.6 mg/dL | Standard Deviation 84.8 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | LDL | 65.2 mg/dL | Standard Deviation 15.3 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Baseline (Pre-Transplant) | Non-HDL | 123.4 mg/dL | Standard Deviation 85.3 |
Secondary
Fasting Lipid Profile at Wk 28 Post-Transplant
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.
Time frame: Week 28
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 28 Post-Transplant | Total cholesterol | 169.6 mg/dL | Standard Deviation 38.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 28 Post-Transplant | HDL | 51.0 mg/dL | Standard Deviation 14.5 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 28 Post-Transplant | LDL | 95.6 mg/dL | Standard Deviation 31.4 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 28 Post-Transplant | Triglyceride | 126.4 mg/dL | Standard Deviation 51 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 28 Post-Transplant | Non-HDL | 119.6 mg/dL | Standard Deviation 35.9 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | LDL | 109.8 mg/dL | Standard Deviation 43 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | Total cholesterol | 179.5 mg/dL | Standard Deviation 44.4 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | Non-HDL | 133.5 mg/dL | Standard Deviation 46.7 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | HDL | 46.0 mg/dL | Standard Deviation 18.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | Triglyceride | 153.3 mg/dL | Standard Deviation 93 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | Triglyceride | 166.6 mg/dL | Standard Deviation 128.9 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | HDL | 52.3 mg/dL | Standard Deviation 27.5 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | Total cholesterol | 167.3 mg/dL | Standard Deviation 39.5 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | LDL | 82.7 mg/dL | Standard Deviation 18.2 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 28 Post-Transplant | Non-HDL | 115.0 mg/dL | Standard Deviation 38 |
Secondary
Fasting Lipid Profile at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 52 Post-Transplant | Triglyceride | 125.8 mg/dL | Standard Deviation 93 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 52 Post-Transplant | HDL | 48.5 mg/dL | Standard Deviation 11.3 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 52 Post-Transplant | Non-HDL | 128.6 mg/dL | Standard Deviation 30.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 52 Post-Transplant | Total cholesterol | 177.1 mg/dL | Standard Deviation 25.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Fasting Lipid Profile at Wk 52 Post-Transplant | LDL | 102.9 mg/dL | Standard Deviation 17.7 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | Total cholesterol | 163.7 mg/dL | Standard Deviation 38.8 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | HDL | 42.4 mg/dL | Standard Deviation 15.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | Triglyceride | 170.0 mg/dL | Standard Deviation 118.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | LDL | 86.3 mg/dL | Standard Deviation 50.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | Non-HDL | 121.2 mg/dL | Standard Deviation 32 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | Triglyceride | 182.8 mg/dL | Standard Deviation 84.2 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | LDL | 94.6 mg/dL | Standard Deviation 46.4 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | HDL | 44.0 mg/dL | Standard Deviation 14.9 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | Total cholesterol | 174.8 mg/dL | Standard Deviation 54.7 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Fasting Lipid Profile at Wk 52 Post-Transplant | Non-HDL | 130.8 mg/dL | Standard Deviation 45.6 |
Secondary
Hemoglobin A1c (HbA1c) Measurements Over Time
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.
Time frame: Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Hemoglobin A1c (HbA1c) Measurements Over Time | Baseline | 5.7 percentage | Standard Deviation 1.3 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Hemoglobin A1c (HbA1c) Measurements Over Time | Day 28 | 5.4 percentage | Standard Deviation 0.8 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Hemoglobin A1c (HbA1c) Measurements Over Time | Day 84 | 5.6 percentage | Standard Deviation 1.1 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 28 | 6.2 percentage | Standard Deviation 1.9 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 36 | 6.7 percentage | Standard Deviation 2.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 52 | 7.8 percentage | Standard Deviation 3.3 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 52 | 6.7 percentage | Standard Deviation 1.6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Baseline | 5.7 percentage | Standard Deviation 1.1 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 28 | 6.0 percentage | Standard Deviation 1.4 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 36 | 5.9 percentage | Standard Deviation 1.2 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Day 28 | 5.6 percentage | Standard Deviation 1 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Day 84 | 5.5 percentage | Standard Deviation 1.1 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Day 28 | 5.4 percentage | Standard Deviation 1.1 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Day 84 | 5.4 percentage | Standard Deviation 0.8 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 52 | 5.8 percentage | Standard Deviation 1.3 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 28 | 5.6 percentage | Standard Deviation 0.8 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Baseline | 5.9 percentage | Standard Deviation 0.8 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Hemoglobin A1c (HbA1c) Measurements Over Time | Week 36 | 5.5 percentage | Standard Deviation 0.8 |
Secondary
Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant | 56.1 mL/min/1.73m^2 | Standard Deviation 18.5 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant | 57.0 mL/min/1.73m^2 | Standard Deviation 20.7 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant | 58.2 mL/min/1.73m^2 | Standard Deviation 14.4 |
Secondary
Standardized Blood Pressure Measurement at Wk 52 Post-Transplant
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.
Time frame: Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | Systolic BP at W52 | 135.0 mmHg | Standard Deviation 18.9 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | Diastolic BP at W52 | 77.7 mmHg | Standard Deviation 10.9 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | Systolic BP at W52 | 133.7 mmHg | Standard Deviation 14.7 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | Diastolic BP at W52 | 79.1 mmHg | Standard Deviation 10.2 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | Systolic BP at W52 | 132.0 mmHg | Standard Deviation 8.7 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Standardized Blood Pressure Measurement at Wk 52 Post-Transplant | Diastolic BP at W52 | 75.7 mmHg | Standard Deviation 13.1 |
Secondary
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine 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.
Time frame: Day 28 through Week 52 Post-Transplant
Population: Intent-to-treat population with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant | 0.3 eGFR change over time (by month) | Standard Deviation 4.1 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant | 1.3 eGFR change over time (by month) | Standard Deviation 2.6 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant | 0.8 eGFR change over time (by month) | Standard Deviation 1.4 |
Secondary
Total Daily Prescribed Pill Count
This is a measure of the total number of pills a participant was prescribed on a given day
Time frame: Day 28, Day 84, Week 28, Week 36, and Week 52
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Total Daily Prescribed Pill Count | Week 28 | 19.7 pills per day | Standard Deviation 7.2 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Total Daily Prescribed Pill Count | Week 36 | 19.1 pills per day | Standard Deviation 8 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Total Daily Prescribed Pill Count | Day 84 | 22.2 pills per day | Standard Deviation 6.3 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Total Daily Prescribed Pill Count | Week 52 | 24.4 pills per day | Standard Deviation 11.8 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Total Daily Prescribed Pill Count | Day 28 | 25.8 pills per day | Standard Deviation 9.9 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Day 84 | 17.2 pills per day | Standard Deviation 6.3 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Week 28 | 15.5 pills per day | Standard Deviation 6 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Day 28 | 18.9 pills per day | Standard Deviation 7.5 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Week 36 | 15.4 pills per day | Standard Deviation 4.8 |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Week 52 | 15.7 pills per day | Standard Deviation 5.4 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Week 52 | 13.7 pills per day | Standard Deviation 5.1 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Week 36 | 13.9 pills per day | Standard Deviation 5.9 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Day 84 | 21.0 pills per day | Standard Deviation 7 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Week 28 | 16.6 pills per day | Standard Deviation 8.1 |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Total Daily Prescribed Pill Count | Day 28 | 23.5 pills per day | Standard Deviation 8.9 |
Secondary
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies
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
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. III | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline | 3 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. II | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | AMR-Gd. II (Capillary/Glomerular) | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA, IFTA-Gd. II | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | IFTA-Gd. II | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. III | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, Chr.AMR, IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd. I (ATN-Like) | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IIA, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | IFTA-Gd. I | 4 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IIA | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, IFTA- Gd. II | 2 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1 | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | AMR-Gd. II (Capillary/Glomerular) | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline | 5 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1 | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, Chr.AMR, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, IFTA-Gd. I | 2 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, IFTA- Gd. II | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA | 4 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA, IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA, IFTA-Gd. II | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. II | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. III | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IIA | 2 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IIA, IFTA-Gd. I | 2 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. III | 2 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd. I (ATN-Like) | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | IFTA-Gd. I | 5 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | IFTA-Gd. II | 2 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | AMR-Gd. II (Capillary/Glomerular) | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. III | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd. I (ATN-Like) | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IIA | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, Chr.AMR, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | IFTA-Gd. II | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IIA, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA, IFTA-Gd. II | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. III | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA, IFTA-Gd. I | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1 | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. I | 1 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IA | 2 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | ACR-Gd. IB, IFTA-Gd. II | 1 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies | Borderline, IFTA- Gd. II | 0 Biopsy |
Secondary
Type of Treatment for Detected Graft Rejection
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
Time frame: Transplantation through Week 52
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | ATG, Pulse Steroids, Prograf | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Antibiotic | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Prednisone | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Pulse Steroids, Leflunomide | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Plasmapheresis | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Pulse Steroids, Plasmapheresis, Eculizumab | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | ATG, Pulse Steroids | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Plasmapheresis, Oral Steroids | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | ATG | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac | Type of Treatment for Detected Graft Rejection | Pulse Steroids | 6 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | ATG, Pulse Steroids | 5 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Pulse Steroids | 9 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Pulse Steroids, Leflunomide | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Pulse Steroids, Plasmapheresis, Eculizumab | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Prednisone | 2 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | ATG, Pulse Steroids, Prograf | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | ATG | 1 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Antibiotic | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Plasmapheresis | 0 Biopsy |
| Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Plasmapheresis, Oral Steroids | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Prednisone | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | ATG | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | ATG, Pulse Steroids | 2 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | ATG, Pulse Steroids, Prograf | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Antibiotic | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Plasmapheresis | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Plasmapheresis, Oral Steroids | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Pulse Steroids, Leflunomide | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Pulse Steroids, Plasmapheresis, Eculizumab | 0 Biopsy |
| Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept | Type of Treatment for Detected Graft Rejection | Pulse Steroids | 3 Biopsy |