Trial Outcomes & Findings for Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (NCT NCT00906204)

Last Updated: 2015-12-07

Results Overview

The composite endpoint components and definitions are: * Fever: Body temperature ≥ 38.5˚C. * Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors. * Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for \> 12 hours out of a 24 hour period. * Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia) * Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

During first 7 days after kidney transplantation

Results posted on

2015-12-07

Participant Flow

Trial enrollment occurred between 3/30/2010 and 3/25/2014. Patients scheduled to undergo kidney transplantation were evaluated for trial suitability/enrollment in the transplant hospital or clinic just before transplantation, typically from a few hours to \~24 hours before transplantation.

Occasionally patients were evaluated and thought to be suitable trial candidates until transplantation was imminent, when they were ruled out by last-minute observation of medical problems or donor shortcomings.

Participant milestones

Participant milestones
Measure	Single-dose Thymoglobulin Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Primary Endpoint (Early Safety) STARTED	45	52
Primary Endpoint (Early Safety) COMPLETED	43	51
Primary Endpoint (Early Safety) NOT COMPLETED	2	1
Secondary Endpoints (Long-term Safety) STARTED	43	51
Secondary Endpoints (Long-term Safety) COMPLETED	41	48
Secondary Endpoints (Long-term Safety) NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Single-dose Thymoglobulin Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Primary Endpoint (Early Safety) Physician Decision	1	0
Primary Endpoint (Early Safety) Untransplantable donor kidney	0	1
Primary Endpoint (Early Safety) Withdrawal by Subject	1	0
Secondary Endpoints (Long-term Safety) Adverse Event	2	2
Secondary Endpoints (Long-term Safety) Death	0	1

Baseline Characteristics

Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-dose Thymoglobulin n=44 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 11.8 • n=5 Participants	49.0 years STANDARD_DEVIATION 12.4 • n=7 Participants	48.5 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	38 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	51 participants n=7 Participants	95 participants n=5 Participants
Type of kidney donor Living donor	26 participants n=5 Participants	29 participants n=7 Participants	55 participants n=5 Participants
Type of kidney donor Deceased donor	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: During first 7 days after kidney transplantation

Outcome measures

Outcome measures
Measure	Single-dose Thymoglobulin n=44 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function	13 participants	12 participants

SECONDARY outcome

Timeframe: 12 months post-transplantation

Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.

Outcome measures

Outcome measures
Measure	Single-dose Thymoglobulin n=44 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Patient Survival	44 participants	50 participants

SECONDARY outcome

Timeframe: 12 months post-transplantation

Kaplan-Meier estimates of graft survival probability for 12 months after transplantation

Outcome measures

Outcome measures
Measure	Single-dose Thymoglobulin n=44 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Graft Survival	42 participants	50 participants

SECONDARY outcome

Timeframe: 12 months post-transplantation

Kaplan-Meier probability estimates of rejection rates

Outcome measures

Outcome measures
Measure	Single-dose Thymoglobulin n=44 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Acute Kidney Rejection	5 participants	5 participants

SECONDARY outcome

Timeframe: First 7 days post-transplantation

Outcome measures

Outcome measures
Measure	Single-dose Thymoglobulin n=44 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Incomplete Thymoglobulin Infusion	3 participants	5 participants

SECONDARY outcome

Timeframe: 12 months post-transplantation

Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)

Outcome measures

Outcome measures
Measure	Single-dose Thymoglobulin n=41 Participants Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=50 Participants Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Kidney Function	59.3 mL/min/1.73m^2 Standard Deviation 15.6	61.3 mL/min/1.73m^2 Standard Deviation 23.3

Adverse Events

Single-dose Thymoglobulin

Serious events: 23 serious events

Other events: 44 other events

Deaths: 0 deaths

Divided-dose Thymoglobulin

Serious events: 21 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. R. Brian Stevens, MD, PhD, FACS

Wright State University Boonshoft School of Medicine, Dayton, Ohio, USA

Phone: 937-545-4817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Single-dose Thymoglobulin n=44 participants at risk Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 participants at risk Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Blood and lymphatic system disorders anemia	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Blood and lymphatic system disorders serum sickness	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders atrial fibrillation	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders Myocardial infarction	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders Congestive heart failure	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders Atypical chest pain	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders hyperkalemia	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders abdominal fullness	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders abdominal pain	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders diarrhea	4.5% 2/44 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders hemorrhage	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders nausea	4.5% 2/44 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
General disorders death	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
General disorders orthostatic hypotension	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Hepatobiliary disorders cholangitis	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Hepatobiliary disorders hepatitis C exposure	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Immune system disorders Leukopenia	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations BK virus	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations C. difficile	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Pneumonia	9.1% 4/44 • Number of events 4 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Histoplasmosis	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Sepsis	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Urinary tract infection	2.3% 1/44 • Number of events 3 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Influenza	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Viral Gasteroenteritis	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Injury, poisoning and procedural complications rATG reaction	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphoid leukemia	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Nervous system disorders Seizures	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Acute tubular necrosis	4.5% 2/44 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Delayed graft function	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Interstitial nephritis	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Native nephrectomy	2.3% 1/44 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Nephrostomy tube placement	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Perinephric hematoma	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Rejection	6.8% 3/44 • Number of events 3 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • Number of events 2 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Renal vein thrombosis	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Urinary retention	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	2.0% 1/51 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.3% 1/44 • Number of events 1 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.

Other adverse events
Measure	Single-dose Thymoglobulin n=44 participants at risk Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation	Divided-dose Thymoglobulin n=51 participants at risk Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Endocrine disorders Hyperkalemia	18.2% 8/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	23.5% 12/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Hyperparathyroidism	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	5.9% 3/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Hyperphosphatemia	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	13.7% 7/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Hypokalemia	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	13.7% 7/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Hypomagnesemia	34.1% 15/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	23.5% 12/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Hypophosphatemia	13.6% 6/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	11.8% 6/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Hyperglycemia	40.9% 18/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	41.2% 21/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Blood and lymphatic system disorders Anemia	31.8% 14/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	27.5% 14/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Blood and lymphatic system disorders Hemorrhage	6.8% 3/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	13.7% 7/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Blood and lymphatic system disorders Thrombocytopenia	31.8% 14/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	27.5% 14/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders Hypertension	25.0% 11/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	29.4% 15/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders Hypotension	9.1% 4/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	9.8% 5/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Cardiac disorders Tachycardia	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Endocrine disorders Osteopenia	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	7.8% 4/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders Abdominal pain	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	5.9% 3/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders Constipation	9.1% 4/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	13.7% 7/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders Diarrhea	25.0% 11/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	19.6% 10/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders Gastric reflux	6.8% 3/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	9.8% 5/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Gastrointestinal disorders Nausea	9.1% 4/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	13.7% 7/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
General disorders Edema	9.1% 4/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	17.6% 9/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
General disorders Orthostatic hypotension	4.5% 2/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	7.8% 4/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
General disorders Tacrolimus elevation/toxicity	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Hepatobiliary disorders Elevated liver enzymes	4.5% 2/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	7.8% 4/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Immune system disorders Leukocytosis	6.8% 3/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	19.6% 10/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Immune system disorders Leukopenia	27.3% 12/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	35.3% 18/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Immune system disorders Neutropenia	2.3% 1/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	5.9% 3/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations BK virus	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	11.8% 6/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Immune system disorders Pancytopenia	4.5% 2/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	5.9% 3/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations C. difficile	6.8% 3/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	0.00% 0/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Respiratory infection	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	11.8% 6/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Infections and infestations Urinary tract infection	22.7% 10/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	21.6% 11/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Injury, poisoning and procedural complications Possible rATG reaction	4.5% 2/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	11.8% 6/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Metabolism and nutrition disorders Metabolic acidosis	15.9% 7/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	13.7% 7/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Metabolism and nutrition disorders Hyperlipidemia	15.9% 7/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Nervous system disorders Tremor	0.00% 0/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	9.8% 5/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Dysuria	6.8% 3/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	3.9% 2/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Elevated serum creatinine	18.2% 8/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	19.6% 10/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Proteinuria	11.4% 5/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	7.8% 4/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Renal and urinary disorders Rejection	4.5% 2/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	7.8% 4/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Respiratory, thoracic and mediastinal disorders Shortness of breath	4.5% 2/44 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.	9.8% 5/51 • One year. Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.