Optimization of NULOJIX® Usage Towards Minimizing CNI Exp... | NCT01790594

ID	Type	Description	Link
U01AI084150	U.S. NIH Grant/Contract		View source
NIAID CRMS ID#: 20117	Other Identifier	DAIT NIAID
SDY1433	Other Identifier	ImmPort

Name	Class
Clinical Trials in Organ Transplantation	NETWORK
Rho Federal Systems Division, Inc.	INDUSTRY
Bristol-Myers Squibb	INDUSTRY

Label	Type	Description	Intervention Names
Immunosuppression without Belatacept	Active Comparator	Induction: 5 day course of methylprednisolone or equivalent; Induction: Anti-thymocyte Globulin (Rabbit); Maintenance Immunosuppression: Tacrolimus (or generic). The site investigator will identify a starting tacrolimus dose at his or her discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. Tacrolimus dosing will be initiated on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed, then adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter. Maintenance Immunosuppression: Mycophenolate mofetil (or Myfortic (mycophenolate sodium), or generic).	Drug: methylprednisolone Biological: Anti-thymocyte Globulin (Rabbit) Drug: Tacrolimus Drug: Mycophenolate mofetil
Immunosuppression Including Belatacept	Experimental	Induction: 5 day course of methylprednisolone or equivalent; Induction: Anti-thymocyte Globulin (Rabbit); Maintenance Immunosuppression: Belatacept Maintenance Immunosuppression: Tacrolimus (or generic)- The site investigator will identify a starting tacrolimus dose at his or her discretion, in order to achieve the target trough levels no later than 5 days post-transplantation. Tacrolimus dosing will be initiated on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed. The dosage will be adjusted to achieve the following therapeutic trough levels: 5-8 ng/ml during the first 24 weeks post-transplant and then 3-5 ng/ml until day 280 (week 40). Subjects may be withdrawn if they meet all the criteria defined below. Maintenance Immunosuppression: Mycophenolate mofetil (or Myfortic (mycophenolate sodium), or generic).	Biological: Belatacept Drug: methylprednisolone Biological: Anti-thymocyte Globulin (Rabbit) Drug: Tacrolimus Drug: Mycophenolate mofetil

Name	Type	Description	Arm Group Labels	Other Names
Belatacept	Biological	The first dose of belatacept will be administered approximately 24-48 hours after the last dose of Anti-Thymocyte Globulin (Rabbit).	Immunosuppression Including Belatacept

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 Post-Transplant

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand and provide written informed consent;
Candidate for a primary simultaneous kidney and pancreas allograft with random c-peptide <0.3 ng/mL;
No known contraindications to study therapy using NULOJIX® (belatacept);
Female subjects of childbearing potential must have a negative pregnancy test upon study entry;
Female and male participants with reproductive potential must agree to use FDA approved methods of birth control during participation in the study and for 4 months following study completion;
No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator;
Negative crossmatch, actual or virtual, or a Panel Reactive Antibodies (PRA) of 0% on historic and admission sera, as determined by each participating study center;
A documented negative Tuberculosis (TB) test within the 12 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed.

Exclusion Criteria:

Need for multi-organ transplantation other than a kidney and pancreas;
Recipient of previous organ transplant;
Epstein-Barr Virus (EBV) sero-negative recipients or recipients whose EBV serostatus is unknown prior to the time of transplantation;
Individuals infected by the hepatitis B or C viruses or HIV;
Individuals who have required treatment with systemic prednisone or other immunosuppressive drugs within 1 year prior to transplant;
Individuals previously treated with NULOJIX® (belatacept);
Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
Use of investigational drugs within 4 weeks of enrollment;
Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;
Administration of live attenuated vaccine(s) within 8 weeks of enrollment.

Name	Affiliation	Role
Kenneth Newell, MD, PhD	Emory University	Principal Investigator

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

PubMed Identifier	Type	Citation	Retractions
32039559	Result	Stock PG, Mannon RB, Armstrong B, Watson N, Ikle D, Robien MA, Morrison Y, Odorico J, Fridell J, Mehta AK, Newell KA. Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial. Am J Transplant. 2020 Jun;20(6):1668-1678. doi: 10.1111/ajt.15817. Epub 2020 Mar 8.

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

ID	Title	Description
FG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 28, 2016

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 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.

Units	Counts
Participants	OG00021 OG00121

Title

Denominators

Categories

Title	Measurements
	OG00077.0± 22.6 OG00174.6± 19.7

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	The p-value compares Investigational arm and control arm.	Mixed Models Analysis		0.750		Mean Difference (Final Values)	2.088			2-Sided	95	-11.067	15.242					Superiority

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 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 CKD Stage at Wk 52 Post-Transplant

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 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 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 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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

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

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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

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

Posted

Mean

Standard Deviation

eGFR change over time (by month)

Day 28 through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm

Participants achieved successful discontinuation if they were able to discontinue (e.g., off tacrolimus therapy completely) over a 4-8 weeks after tacrolimus withdrawal was initiated at week 40.

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Week 40 through week 48 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.

Units

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

Transplant through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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 Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant

Participants with full pancreatic graft functions are defined as those that no longer require exogenous insulin therapy.

Intent-to-treat population

Posted

Count of Participants

Participants

Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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 Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant

C-peptide is a measure of pancreatic function. The definition of partial pancreatic graft function: a fasting C-peptide levels >0.3ng.mL (0.1nmol.L) plus the participant's continued requirement for exogenous insulin or oral hypoglycemic agent(s).

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

Secondary

Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant

C-peptide is a measure of pancreatic function. The definition of pancreatic loss: a C-peptide value of <0.3 ng/mL.

Intent-to-treat population with available data

Posted

Count of Participants

Participants

Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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

HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant

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

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

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

percent

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

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

Secondary

Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant

Fasting blood sugar (e.g., glucose) test is used to help diagnose diabetes, prediabetes, and gestational diabetes.

Reference fasting blood sugar (glucose) values:

70 to 99 mg/dL is normal
100 to 125 mg/dL is considered prediabetes
126 mg/dL or higher on two separate tests is considered diabetes.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

mg/dL

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

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

Secondary

Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through 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

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

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through 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 stoke and myocardial infarction.

Intent-to-treat population with available data

Posted

Number

Count of Participants

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

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

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 (Pre-Transplant)

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 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 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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

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 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Use of Lipid Lowering Medications at Baseline, 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

Posted

Number

participants

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

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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 Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant

Biopsy-proven acute rejection (AR) of the kidney (renal) or pancreas during the first 52 weeks post-transplant. AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.

AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.
AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded as I, II, or III, with I defined as the mildest form of AR and III being the most severe.

Intent-to-treat population

Posted

Number

Count of Participants

Transplant through Week 52

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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

Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant

AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.

AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.
AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded is I, II, or III, with I defined as the mildest form of AR and III being the most severe.

Intent-to-treat population

Posted

Number

Participants

Transplant through Week 52

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant

Humoral rejection (i.e., antibody mediated rejection) of:

the kidney as defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury determined by local pathology and,
the pancreas as defined by the presence of circulating anti-donor antibodies, and histopathological data including morphologic evidence of microvascular tissue injury and C4d staining in interacinar capillaries determined by local pathology.

Intent-to-treat population with available data

Posted

Number

Count of Participants

Transplant through Week 52

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant

The de novo development of donor-specific antibody (DSA) is associated with an increased risk of graft rejection.

The presence of anti-Histocompatibility Antigen (HLA) antibodies (alloantibodies) is associated with increased risk of acute and chronic injury to the transplant allograft.

Intent-to-treat population with available data

Posted

Number

Count of Participants

Transplant through Week 52

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

Secondary

Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant

Participants are stratified by kidney biopsy results/treatment received.

In the event of a for cause renal (kidney) biopsy:

-The diagnosis of acute cellular rejection (ACR) using the Banff 2007 renal allograft pathology criteria. These criteria for renal allograft biopsies is an international histopathological classification standard. ACR is defined by a renal biopsy demonstrating a Banff 2007 classification of Grade IA or greater, with higher scores indicating more severe rejection. (Ref: Solez K, Colvin RB et al. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant 2008 8(4): 753-60).

Acronyms and abbreviations:

ACR=Acute Cellular Rejection*
Normal*
Borderline* (criteria for ACR not fulfilled)
Gd.=Grade*
IFTA=Interstitial Fibrosis and Tubular Atrophy*
ATG=Anti-thymocyte globulin therapy
IVIG=Intravenous Immunoglobulin therapy
PO=Orally
QD=Daily *Banff 2007 renal allograft pathology criteria

Intent-to-treat population with available data. All participants were considered evaluable for rejection. Only 'for cause' biopsies were performed post-transplant.

Posted

Count of Participants

Participants

Transplant through Week 52

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant

Participants are stratified by kidney biopsy results/treatment received.

Upon having a for-cause biopsy performed, persons often receive treatment for rejection based on the biopsy results, which may or may not reveal signs of rejection. Details of biopsy findings and corresponding treatment are provided for each instance of treatment for rejection.

Results summary format: biopsy results; treatment.

Acronyms and abbreviations:

ACR=Acute Cellular Rejection
IFTA=Interstitial Fibrosis and Tubular Atrophy
ATG=Anti-thymocyte globulin therapy
IVIG=Intravenous Immunoglobulin therapy
Gd =Grade
PO=Orally
QD=Daily

Intent-to-treat population with available data. Only 'for cause' biopsies were performed post-transplant.

Posted

Count of Participants

Participants

Transplant through Week 52

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Event of Death, Graft Loss, or Undetectable C-peptide

This measure counts death, graft loss, or undetectable C-peptide value (e.g., C-peptide <0.3 ng/mL) occurring at any point post-transplant and independent of each other.

Kidney Graft Loss was defined as 90 consecutive days of dialysis dependency.
Pancreas graft loss was defined as returning to exogenous insulin therapy or initiation of oral hypoglycemic agents for greater than 30 days.
Factitious hypoglycemia due to surreptitious insulin administration results in elevated serum insulin levels and low or undetectable C-peptide levels.

Intent-to-treat population with available data.

Posted

Count of Participants

Participants

Transplant through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Adverse events were collected systematically. Counts of all participants who experienced at least one adverse event (AEs, SAEs) by assigned treatment group.

Refer to the Serious Adverse Events and Other Adverse Events tables for more detail.

Intent-to-treat population

Posted

Number

Count of Participants

From Enrollment (Pre-Transplant) to Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

Secondary

Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy

Infections were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization. Displayed are counts of all participants who experienced infection(s) as an adverse event, by treatment group.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplant through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001	Control

Secondary

Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events

Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.

Specific viruses were monitored during this study using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events, diagnosed by test results from the local clinical pathology laboratory.

Intent-to-treat population

Posted

Number

Count of Participants

Transplant through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event

Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples. Displayed are counts of all participants diagnosed with EBV infection as an adverse event by EBV test(s), diagnosed by test results from the local clinical pathology laboratory.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplant through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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 Diagnosed With Malignancy as an Adverse Event

An increased risk/incidence of malignancy is a recognized complication of immunosuppression in recipients of organ transplants. In Phase 3 clinical trials, overall malignancy rates were similar across all treatment groups, with the exception of posttransplant lymphoproliferative disease (PTLD).Displayed are counts of all participants who experienced malignancy reported as an adverse event.

Intent-to-treat population

Posted

Count of Participants

Participants

Transplant through Week 52 Post-Transplant

ID	Title	Description
OG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Ileus	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0013 events3 affected21 at risk EG0020 events0 affected3 at risk
Pancreas transplant rejection	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected22 at risk EG0014 events3 affected21 at risk EG0020 events0 affected3 at risk
Renal and pancreas transplant rejection	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Clostridial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Gangrene	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Haematoma infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Meningitis viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Pancreas infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Pancreatic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Parvovirus infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Pyelonephritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected21 at risk EG0020 events0 affected3 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected22 at risk EG0016 events4 affected21 at risk EG0020 events0 affected3 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Urosepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Chemical burn of skin	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Peripancreatic fluid collection	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Renal transplant torsion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Blood creatinine increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events3 affected21 at risk EG0020 events0 affected3 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Diabetic autonomic neuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected22 at risk EG00111 events10 affected21 at risk EG0020 events0 affected3 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events2 affected21 at risk EG0020 events0 affected3 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected22 at risk EG0016 events3 affected21 at risk EG0020 events0 affected3 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0015 events5 affected21 at risk EG0020 events0 affected3 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
BK virus infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected22 at risk EG0013 events3 affected21 at risk EG0020 events0 affected3 at risk
Clostridial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0014 events3 affected21 at risk EG0020 events0 affected3 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0006 events3 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected21 at risk EG0020 events0 affected3 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00012 events8 affected22 at risk EG0014 events3 affected21 at risk EG0020 events0 affected3 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events3 affected21 at risk EG0020 events0 affected3 at risk
Amylase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Blood creatinine increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 events3 affected22 at risk EG0014 events3 affected21 at risk EG0020 events0 affected3 at risk
Lipase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0013 events3 affected21 at risk EG0020 events0 affected3 at risk
Weight increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected22 at risk EG0016 events5 affected21 at risk EG0020 events0 affected3 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0013 events3 affected21 at risk EG0020 events0 affected3 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected21 at risk EG0020 events0 affected3 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected21 at risk EG0020 events0 affected3 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected22 at risk EG0013 events2 affected21 at risk EG0020 events0 affected3 at risk

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

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

ID	Title	Description
BG000	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
BG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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	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	Investigational	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.	1	22	20	22	20	22
EG001	Control	Induction: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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	21	19	21	19	21
EG002	Enrolled, Not Randomized	Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.	0	3	0	3	0	3