Trial Outcomes & Findings for Effects of Inhibiting Early Inflammation in Kidney Transplant Patients (NCT NCT02495077)

Last Updated: 2022-08-16

Results Overview

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

290 participants

Primary outcome timeframe

24-Month post-transplantation

Results posted on

2022-08-16

Participant Flow

Fifteen sites consented 290 participants for evaluation of eligibility criteria. 242 participants were determined to be eligible and enrolled into this trial.

290 potential participants signed an informed consent before undergoing any study procedures. After the informed consent was signed and the participant was determined to meet entry criteria, the participant was enrolled in the study. A total of 242 were determined eligible to start the study.

Participant milestones

Participant milestones
Measure	Experimental The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Enrolled, Discontinued Pre-Transplant Participants who were eligible and enrolled but withdrew from the study prior to receiving a transplant.	Screen Failure Participants who were consented but did not meet inclusion/exclusion criteria.
Overall Study STARTED	113	112	17	48
Overall Study COMPLETED	93	91	0	0
Overall Study NOT COMPLETED	20	21	17	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Enrolled, Discontinued Pre-Transplant Participants who were eligible and enrolled but withdrew from the study prior to receiving a transplant.	Screen Failure Participants who were consented but did not meet inclusion/exclusion criteria.
Overall Study Adverse Event	0	1	1	0
Overall Study Death	3	5	0	0
Overall Study Lost to Follow-up	6	4	0	0
Overall Study Physician Decision	2	1	4	0
Overall Study Protocol Violation	0	1	0	0
Overall Study Screen Failure	0	0	0	48
Overall Study Withdrawal by Subject	7	7	7	0
Overall Study Covid-19 research restrictions	1	0	0	0
Overall Study Visit 14 scheduling difficulties	1	0	0	0
Overall Study Incarcerated	0	1	0	0
Overall Study Transplant nephrectomy, patient decision	0	1	0	0
Overall Study Timing of transplant and randomization	0	0	5	0

Baseline Characteristics

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=113 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Total n=225 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	93 Participants n=93 Participants	96 Participants n=4 Participants	189 Participants n=27 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants	16 Participants n=4 Participants	36 Participants n=27 Participants
Age, Continuous	53.2 years STANDARD_DEVIATION 10.70 • n=93 Participants	53.6 years STANDARD_DEVIATION 10.69 • n=4 Participants	53.4 years STANDARD_DEVIATION 10.67 • n=27 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	48 Participants n=4 Participants	90 Participants n=27 Participants
Sex: Female, Male Male	71 Participants n=93 Participants	64 Participants n=4 Participants	135 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=93 Participants	12 Participants n=4 Participants	29 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=93 Participants	99 Participants n=4 Participants	195 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Black or African American	40 Participants n=93 Participants	46 Participants n=4 Participants	86 Participants n=27 Participants
Race (NIH/OMB) White	51 Participants n=93 Participants	48 Participants n=4 Participants	99 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants
Region of Enrollment Canada	2 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment United States	111 participants n=93 Participants	110 participants n=4 Participants	221 participants n=27 Participants
Reason for Transplant Diabetes	28 Participants n=93 Participants	32 Participants n=4 Participants	60 Participants n=27 Participants
Reason for Transplant Glomerular disease	21 Participants n=93 Participants	18 Participants n=4 Participants	39 Participants n=27 Participants
Reason for Transplant Hypertension	24 Participants n=93 Participants	23 Participants n=4 Participants	47 Participants n=27 Participants
Reason for Transplant Polycystic kidney disease	15 Participants n=93 Participants	10 Participants n=4 Participants	25 Participants n=27 Participants
Reason for Transplant Other	25 Participants n=93 Participants	29 Participants n=4 Participants	54 Participants n=27 Participants
Donor Cause of Death CVA	34 Participants n=93 Participants	22 Participants n=4 Participants	56 Participants n=27 Participants
Donor Cause of Death Non-CVA	79 Participants n=93 Participants	90 Participants n=4 Participants	169 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24-Month post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Outcome measures

Outcome measures
Measure	Experimental n=111 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=109 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.	52.45 mL/min/1.73m2 Interval 48.38 to 56.52	57.35 mL/min/1.73m2 Interval 53.18 to 61.52

SECONDARY outcome

Timeframe: 6 month post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. 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.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

Outcome measures

Outcome measures
Measure	Experimental n=71 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=66 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)	4.2 percentage of participants Interval 0.9 to 11.9	3.0 percentage of participants Interval 0.4 to 10.5

SECONDARY outcome

Timeframe: 24 months post-transplantation

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. 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. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=71 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).	5.1 percentage of participants Interval 1.4 to 12.6	4.2 percentage of participants Interval 0.9 to 11.9

SECONDARY outcome

Timeframe: 6 month post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who had ACR within the first 6 months.

Outcome measures

Outcome measures
Measure	Experimental n=3 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=2 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
BANFF Grades of First Acute Cellular Rejections (ACR). IA	1 Participants	1 Participants
BANFF Grades of First Acute Cellular Rejections (ACR). IB	1 Participants	0 Participants
BANFF Grades of First Acute Cellular Rejections (ACR). IIA	1 Participants	1 Participants
BANFF Grades of First Acute Cellular Rejections (ACR). IIB	0 Participants	0 Participants
BANFF Grades of First Acute Cellular Rejections (ACR). III	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months post-transplantation

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

Outcome measures

Outcome measures
Measure	Experimental n=71 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=66 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.	8.5 percentage of participants Interval 3.2 to 17.5	6.1 percentage of participants Interval 1.7 to 14.8

SECONDARY outcome

Timeframe: 24 months post-transplantation

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=71 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection	12.8 percentage of participants Interval 6.3 to 22.3	7 percentage of participants Interval 2.3 to 15.7

SECONDARY outcome

Timeframe: 6 months post-transplantation

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.

Outcome measures

Outcome measures
Measure	Experimental n=71 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=66 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)	0.0 Participants	0.0 Participants

SECONDARY outcome

Timeframe: 24 months post-transplantation

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=71 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).	1.3 percentage of participant Interval 0.0 to 6.9	0.0 percentage of participant Confidence limits not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: 6 months post-transplantation

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present.

Outcome measures

Outcome measures
Measure	Experimental n=71 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=66 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR	2.8 percentage of participants Interval 0.3 to 9.8	0.0 percentage of participants Confidence limits not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: 24 months post-transplantation

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=71 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.	3.8 percentage of participants Interval 0.8 to 10.8	1.4 percentage of participants Interval 0.0 to 7.6

SECONDARY outcome

Timeframe: 6 months post-transplantation

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.

Outcome measures

Outcome measures
Measure	Experimental n=71 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=66 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
BANFF Grades of First AMR.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months post-transplantation

The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be \> or equal to 2.

Outcome measures

Outcome measures
Measure	Experimental n=26 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=22 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.	73.1 percentage of participants Interval 52.2 to 88.4	36.4 percentage of participants Interval 17.2 to 59.3

SECONDARY outcome

Timeframe: 24 months post-transplantation

The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. For this endpoint, the sum of ci+ct scores from the implantation biopsy was subtracted from the sum of the ci+ct scores from the month 24 biopsy and the difference between the two time points was classified as 0, 1, 2, or 3+. Higher values of this difference indicate more severe disease.

Outcome measures

Outcome measures
Measure	Experimental n=26 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=18 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in BANFF Chronicity Scores Between Implantation and the 24 Month Biopsy. 0	4 Participants	6 Participants
Change in BANFF Chronicity Scores Between Implantation and the 24 Month Biopsy. 1	6 Participants	6 Participants
Change in BANFF Chronicity Scores Between Implantation and the 24 Month Biopsy. 2	9 Participants	2 Participants
Change in BANFF Chronicity Scores Between Implantation and the 24 Month Biopsy. 3+	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months post-transplantation

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant.

Outcome measures

Outcome measures
Measure	Experimental n=95 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=83 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.	12.6 percentage of participants Interval 6.7 to 21.0	20.5 percentage of participants Interval 12.4 to 30.8

SECONDARY outcome

Timeframe: 24 months post-transplantation

Outcome measures

Outcome measures
Measure	Experimental n=99 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=89 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.	16.2 percentage of participants Interval 9.5 to 24.9	27 percentage of participants Interval 18.1 to 37.4

SECONDARY outcome

Timeframe: 3 months and 24 months post-transplantation

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24.

Outcome measures

Outcome measures
Measure	Experimental n=38 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=41 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in eGFR Between 3 Months and 24 Months as Measured by MDRD	2.8 mL/min/1.73m2 Standard Deviation 15.06	4.8 mL/min/1.73m2 Standard Deviation 13.26

SECONDARY outcome

Timeframe: 3 months and 24 months post-transplantation

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24.

Outcome measures

Outcome measures
Measure	Experimental n=38 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=41 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI	2.7 mL/min/1.73m2 Standard Deviation 16.38	4.4 mL/min/1.73m2 Standard Deviation 13.91

SECONDARY outcome

Timeframe: 6 months and 24 months post-transplantation

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

Outcome measures

Outcome measures
Measure	Experimental n=42 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=42 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD	8.1 mL/min/1.73m2 Standard Deviation 14.06	11.6 mL/min/1.73m2 Standard Deviation 14.69

SECONDARY outcome

Timeframe: 6 months and 24 months post-transplantation

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

Outcome measures

Outcome measures
Measure	Experimental n=42 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=42 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI	8.5 mL/min/1.73m2 Standard Deviation 15.21	12.0 mL/min/1.73m2 Standard Deviation 15.36

SECONDARY outcome

Timeframe: 6 months and 24 months post-transplantation

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

Outcome measures

Outcome measures
Measure	Experimental n=39 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=36 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in eGFR Between 6 Months and 24 Months as Measured by MDRD	1.0 mL/min/1.73m2 Standard Deviation 11.73	5.2 mL/min/1.73m2 Standard Deviation 13.05

SECONDARY outcome

Timeframe: 6 months and 24 months post-transplantation

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

Outcome measures

Outcome measures
Measure	Experimental n=39 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=36 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI	0.8 mL/min/1.73m2 Standard Deviation 12.67	4.8 mL/min/1.73m2 Standard Deviation 13.42

SECONDARY outcome

Timeframe: Day 7 post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

Outcome measures

Outcome measures
Measure	Experimental n=112 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=110 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
eGFR Values as Measured by MDRD	38.93 mL/min/1.73m2 Interval 35.88 to 41.97	39.96 mL/min/1.73m2 Interval 36.88 to 43.04

SECONDARY outcome

Timeframe: Days 30, 60, and 180 post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

Outcome measures

Outcome measures
Measure	Experimental n=111 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=109 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
eGFR Values as Measured by MDRD Day 30	46.64 mL/min/1.73m2 Interval 43.36 to 49.92	48.20 mL/min/1.73m2 Interval 44.89 to 51.51
eGFR Values as Measured by MDRD Day 90	47.14 mL/min/1.73m2 Interval 43.9 to 50.38	48.99 mL/min/1.73m2 Interval 45.71 to 52.26
eGFR Values as Measured by MDRD Day 180	47.89 mL/min/1.73m2 Interval 44.66 to 51.11	50.16 mL/min/1.73m2 Interval 46.9 to 53.42

SECONDARY outcome

Timeframe: Day 7 post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

Outcome measures

Outcome measures
Measure	Experimental n=112 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=110 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
eGFR Values as Measured by CKD-EPI	41.01 mL/min/1.73m2 Interval 37.68 to 44.33	41.85 mL/min/1.73m2 Interval 38.49 to 45.22

SECONDARY outcome

Timeframe: Days 30, 90, and 180 post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

Outcome measures

Outcome measures
Measure	Experimental n=111 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=109 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
eGFR Values as Measured by CKD-EPI Day 30	49.29 mL/min/1.73m2 Interval 45.72 to 52.85	50.63 mL/min/1.73m2 Interval 47.03 to 54.24
eGFR Values as Measured by CKD-EPI Day 90	49.80 mL/min/1.73m2 Interval 46.27 to 53.32	51.44 mL/min/1.73m2 Interval 47.87 to 55.0
eGFR Values as Measured by CKD-EPI Day 180	50.56 mL/min/1.73m2 Interval 47.05 to 54.07	52.65 mL/min/1.73m2 Interval 49.09 to 56.2

SECONDARY outcome

Timeframe: 24 months post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days.

Outcome measures

Outcome measures
Measure	Experimental n=113 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Death or Graft Failure.	5.3 percentage of participants Interval 2.0 to 11.2	7.1 percentage of participants Interval 3.1 to 13.6

SECONDARY outcome

Timeframe: 24 months post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days.

Outcome measures

Outcome measures
Measure	Experimental n=113 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Only Graft Failure.	2.7 percentage of participants Interval 0.6 to 7.6	2.7 percentage of participants Interval 0.6 to 7.6

SECONDARY outcome

Timeframe: 1 week post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant.

Outcome measures

Outcome measures
Measure	Experimental n=113 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants That Required at Least One Dialysis Treatment.	31.0 percentage of participants Interval 22.6 to 40.4	35.7 percentage of participants Interval 26.9 to 45.3

SECONDARY outcome

Timeframe: 8 weeks post-transplantation

The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint.

Outcome measures

Outcome measures
Measure	Experimental n=111 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=109 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Number of Dialysis Sessions.	0.14 Dialysis sessions Standard Deviation 1.0	0.26 Dialysis sessions Standard Deviation 2.32

SECONDARY outcome

Timeframe: First post-transplant dialysis treatment to last post-transplant dialysis treatment

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment.

Outcome measures

Outcome measures
Measure	Experimental n=33 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=39 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.	13.27 Days Standard Deviation 13.89	15.74 Days Standard Deviation 38.37

SECONDARY outcome

Timeframe: Transplantation through at least month 3 up to month 24

Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition.

Outcome measures

Outcome measures
Measure	Experimental n=109 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=107 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.	2.8 Percent of Participants Interval 0.6 to 7.8	0.9 Percent of Participants Interval 0.0 to 5.1

SECONDARY outcome

Timeframe: 24, 48 and 72 hours post-transplantation

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. eGFR values from 24, 48, and 72 hours post-transplant (i.e., days 1, 2, and 3) were used to generate an estimate of the serum creatinine at each time point of interest for each treatment group.

Outcome measures

Outcome measures
Measure	Experimental n=113 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=111 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Change From Baseline (Immediately After Surgery) in Serum Creatinine. 72 Hours	5.77 mg/dL Interval 5.16 to 6.37	5.21 mg/dL Interval 4.6 to 5.81
Change From Baseline (Immediately After Surgery) in Serum Creatinine. 24 Hours	7.35 mg/dL Interval 6.74 to 7.95	6.85 mg/dL Interval 6.24 to 7.46
Change From Baseline (Immediately After Surgery) in Serum Creatinine. 48 Hours	6.24 mg/dL Interval 5.64 to 6.84	5.87 mg/dL Interval 5.26 to 6.48

SECONDARY outcome

Timeframe: 24 months post-transplantation

Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date.

Outcome measures

Outcome measures
Measure	Experimental n=96 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=92 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)	642 Days to event Interval 370.0 to 1054.0	613 Days to event Interval 226.0 to the upper confidence limit is not estimable due to insufficient number of participants with events after reaching the median time point

SECONDARY outcome

Timeframe: Day 5 post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available serum creatinine data at day 5 post-transplant.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=70 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.	47.4 percentage of participants Interval 36.0 to 59.1	42.9 percentage of participants Interval 31.1 to 55.3

SECONDARY outcome

Timeframe: Day 2 post-transplantation

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function.

Outcome measures

Outcome measures
Measure	Experimental n=77 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=70 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery	24.28 Percentage Standard Deviation 22.60	20.97 Percentage Standard Deviation 16.64

SECONDARY outcome

Timeframe: Day 5 post-transplantation

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=69 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.	47.06 Percentage Standard Deviation 28.86	43.37 Percentage Standard Deviation 25.79

SECONDARY outcome

Timeframe: Day 5 post-transplantation

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=69 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.	74.4 percentage of participants Interval 63.2 to 83.6	88.4 percentage of participants Interval 78.4 to 94.9

SECONDARY outcome

Timeframe: Day 2 post-transplantation

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%.

Outcome measures

Outcome measures
Measure	Experimental n=77 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=70 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.	57.1 percentage of participants Interval 45.4 to 68.4	68.6 percentage of participants Interval 56.4 to 79.1

SECONDARY outcome

Timeframe: 1 week to 24 months post-transplantation

Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint.

Outcome measures

Outcome measures
Measure	Experimental n=78 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=71 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
The Percent of Participants Who Need Dialysis After Week 1.	9.0 percentage of participants Interval 3.7 to 17.6	2.8 percentage of participants Interval 0.3 to 9.8

SECONDARY outcome

Timeframe: 24 months post-transplantation

Population: Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who had available DSA data.

Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint.

Outcome measures

Outcome measures
Measure	Experimental n=112 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=110 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With de Novo DSA.	8.0 percentage of participants Interval 3.7 to 14.7	3.6 percentage of participants Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: 24 months post-transplantation

Population: Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death.

Outcome measures

Outcome measures
Measure	Experimental n=114 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.	43.0 percentage of participants Interval 33.7 to 52.6	39.3 percentage of participants Interval 30.2 to 49.0

SECONDARY outcome

Timeframe: 24 months post-transplantation

Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection.

Outcome measures

Outcome measures
Measure	Experimental n=114 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Mycobacterial or Fungal Infections	6.1 percentage of participants Interval 2.5 to 12.2	6.3 percentage of participants Interval 2.5 to 12.5

SECONDARY outcome

Timeframe: 24 months post-transplantation

Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy.

Outcome measures

Outcome measures
Measure	Experimental n=114 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site	18.4 percentage of participants Interval 11.8 to 26.8	11.6 percentage of participants Interval 6.3 to 19.0

SECONDARY outcome

Timeframe: 24 months post-transplantation

Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy.

Outcome measures

Outcome measures
Measure	Experimental n=114 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.	28.9 Percent of participants Interval 20.8 to 38.2	13.4 Percent of participants Interval 7.7 to 21.1

SECONDARY outcome

Timeframe: 24 months post-transplantation

Participants were considered to have met this endpoint if they had a reported case of malignancy.

Outcome measures

Outcome measures
Measure	Experimental n=114 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Malignancy.	1.8 Percent of Participants Interval 0.2 to 6.2	0.9 Percent of Participants Interval 0.0 to 4.9

SECONDARY outcome

Timeframe: 24 months post-transplantation

Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia.

Outcome measures

Outcome measures
Measure	Experimental n=114 Participants The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Control n=112 Participants The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision	7.9 Percent of participants Interval 3.7 to 14.5	11.6 Percent of participants Interval 6.3 to 19.0

Adverse Events

Experimental

Serious events: 87 serious events

Other events: 44 other events

Deaths: 3 deaths

Control

Serious events: 82 serious events

Other events: 41 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place