Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Bel... | NCT01856257

Name	Class
Clinical Trials in Organ Transplantation	NETWORK

Label	Type	Description	Intervention Names
Thymoglobulin®+tacrolimus+MMF	Active Comparator	Induction with Thymoglobulin®, methylprednisolone, and maintenance immunosuppression with tacrolimus and mycophenolate mofetil (MMF)	Biological: Anti-thymocyte Globulin (Rabbit) Drug: methylprednisolone Drug: mycophenolate mofetil Drug: tacrolimus
Thymoglobulin®+belatacept+MMF	Experimental	Induction with Thymoglobulin®, methylprednisolone, and maintenance with belatacept and mycophenolate mofetil (MMF)	Biological: Anti-thymocyte Globulin (Rabbit) Biological: belatacept Drug: methylprednisolone Drug: mycophenolate mofetil
Basiliximab+20 weeks of tacrolimus+MMF + belatacept	Experimental	Induction basiliximab and methylprednisolone, administration of NULOJIX® (belatacept) 24 hours post reperfusion (+/-12 hrs); maintenance immunosuppression with 1. )20 week course of Prograf® (tacrolimus) or equivalent 2.) CellCept® (mycophenolate mofetil- MMF), or Myfortic® (mycophenolate sodium), or equivalent. Subjects participating in this arm may have tacrolimus reinstated, at a dose to be determined by the site investigator, if any of the following events occur: 1 - An acute rejection episode 2- Request of the subject or site Investigator.	Biological: belatacept Drug: methylprednisolone Biological: basiliximab Drug: mycophenolate mofetil Drug: tacrolimus

Name	Type	Description	Arm Group Labels	Other Names
Anti-thymocyte Globulin (Rabbit)	Biological	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.

Measure	Description	Time Frame
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.	Week 52

Measure	Description	Time Frame
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.	Transplantation through Week 52
Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant

Name	Affiliation	Role
Kenneth Newell, MD, PhD	Emory University	Principal Investigator
Roslyn B. Mannon, M.D.	University of Alabama at Birmingham	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
University of California, San Francisco

PubMed Identifier	Type	Citation	Retractions
32558199	Result	Mannon RB, Armstrong B, Stock PG, Mehta AK, Farris AB, Watson N, Morrison Y, Sarwal M, Sigdel T, Bridges N, Robien M, Newell KA, Larsen CP. Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial. Am J Transplant. 2020 Dec;20(12):3599-3608. doi: 10.1111/ajt.16152. Epub 2020 Jul 13.

Label	URL
National Institute of Allergy and Infectious Diseases (NIAID)	View source

ID	Title	Description
FG000	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Intent-to-treat population with available data at week 52

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Week 52

ID	Title	Description
OG000	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.
OG001	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.
OG002	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

Units	Counts
Participants	OG00026 OG00127 OG00211

Title

Denominators

Categories

Title	Measurements
	OG00059.2± 19.9 OG00161.5± 23.3 OG00263.0± 17.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		0.544		Mean Difference (Final Values)	3.512			2-Sided	95	-7.999	15.024			The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.		Superiority
OG000

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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.*

Intent-to-treat population

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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.*

Intent-to-treat population

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

eGFR change over time (by month)

Day 28 through Week 52 Post-Transplant

ID	Title	Description
OG000	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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

Intent-to-treat population

Posted

Number

Biopsy

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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

Intent-to-treat population

Posted

Number

Biopsy

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.

Posted

Week 52

ID	Title	Description
OG000	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.
OG001	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.

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).

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.

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.

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Day 14 through week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

percentage

Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

mmHg

Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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.

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

mg/dL

Baseline

ID	Title	Description
OG000	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.

Secondary

Fasting Lipid Profile at Wk 28 Post-Transplant

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

mg/dL

Week 28

ID	Title	Description
OG000	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.

Secondary

Fasting Lipid Profile at Wk 52 Post-Transplant

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.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

mg/dL

Week 52

ID	Title	Description
OG000	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.

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.

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Baseline (Pre-Transplant), Week 28, and Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Total Daily Prescribed Pill Count

This is a measure of the total number of pills a participant was prescribed on a given day

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

pills per day

Day 28, Day 84, Week 28, Week 36, and Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Enrollment through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplantation through Week 52

ID	Title	Description
OG000	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.
OG001	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.

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.

Intent-to-treat population

Posted

Count of Participants

Participants

Within 24 Hours of transplant procedure

ID	Title	Description
OG000	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.
OG001	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.

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG0030 events0 affected2 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events1 affected29 at risk EG0021 events1 affected11 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events1 affected29 at risk EG0021 events1 affected11 at risk EG003
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Kidney transplant rejection	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected11 at risk EG003
Transplant rejection	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG00110 events8 affected29 at risk EG0022 events2 affected11 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected29 at risk EG0021 events1 affected11 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0014 events4 affected29 at risk EG0020 events0 affected11 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected11 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Septic shock	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected29 at risk EG0015 events4 affected29 at risk EG0021 events1 affected11 at risk EG003
Zygomycosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0014 events4 affected29 at risk EG0020 events0 affected11 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Perinephric collection	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Glomerulonephritis minimal lesion	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Renal artery dissection	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Oedema genital	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0008 events7 affected29 at risk EG0015 events5 affected29 at risk EG0023 events3 affected11 at risk EG0030 events0 affected2 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0012 events2 affected29 at risk EG0021 events1 affected11 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected29 at risk EG0013 events3 affected29 at risk EG0021 events1 affected11 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected29 at risk EG0020 events0 affected11 at risk EG003
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Transplant rejection	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0016 events4 affected29 at risk EG0022 events1 affected11 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 events1 affected29 at risk EG0019 events8 affected29 at risk EG0020 events0 affected11 at risk EG003
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0018 events8 affected29 at risk EG0020 events0 affected11 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected11 at risk EG003
White blood cell count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected29 at risk EG0014 events3 affected29 at risk EG0021 events1 affected11 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected29 at risk EG0020 events0 affected11 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0007 events5 affected29 at risk EG0015 events4 affected29 at risk EG0021 events1 affected11 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected11 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0013 events3 affected29 at risk EG0021 events1 affected11 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected29 at risk EG0020 events0 affected11 at risk EG003

ID	Term
D000961	Antilymphocyte Serum
C512542	thymoglobulin
D000069594	Abatacept
D008775	Methylprednisolone
D000077552	Basiliximab
D009173	Mycophenolic Acid
D016559	Tacrolimus

ID	Term
D007106	Immune Sera
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D001688	Biological Products
D045424	Complex Mixtures
D018796	Immunoconjugates
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D018942	Macrolides
D007783	Lactones

ID	Title	Description
BG000	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.
BG001	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.
BG002	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
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	2	29	19	29	15	29
EG001	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.	0	29	21	29	24	29
EG002	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	0	11	6	11	7	11
EG003	Enrolled, Not Randomized	Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.	0	2	0	2	0	2