Reparixin in Prevention of Delayed Graft Function After K... | NCT00248040

Label	Type	Description	Intervention Names
reparixin group - continuous infusion	Experimental	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.	Drug: Reparixin continuous infusion
reparixin group - intermittent infusion	Experimental	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.	Drug: reparixin intermittent infusion
placebo infusion	Placebo Comparator	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.	Other: placebo infusion

Name	Type	Description	Arm Group Labels	Other Names
Reparixin continuous infusion	Drug	The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline.

Measure	Description	Time Frame
Creatinine Clearance (CrCl) in the Immediate Post-transplant Period	CrCl was determined by two 60 minute urine collections, during the time intervals 1-3 and 10-12 hours of allograft reperfusion. Blood was withdrawn at the midpoint of each urine collection. CrCl at each timepoint was calculated according to the formula: creatinine clearance (mL/minutes) = urine creatinine (mmol/L) x urine volume (mL) / serum creatinine (mmol/L) x time of collection (minutes) An average was to be calculated from the two 60 minute values in each interval.	1-3 and 10-12 hours post allograft reperfusion

Measure	Description	Time Frame
Renal Function Tests - Serum Creatinine	Serum creatinine (SrCr) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis.	daily up to day 7 post-transplant or hospital discharge

Name	Affiliation	Role
Giuseppe Remuzzi, MD	A.O. Ospedale Papa Giovanni XXIII	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Transplant Center, University of Minnesota Medical School		Minneapolis	Minnesota	55455	United States

ID	Title	Description
FG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
FG001	Reparixin Intermittent Infusion

ID	Title	Description
BG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
BG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
BG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00025 BG00123 BG00226 BG00374

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

Creatinine Clearance (CrCl) in the Immediate Post-transplant Period

CrCl was determined by two 60 minute urine collections, during the time intervals 1-3 and 10-12 hours of allograft reperfusion. Blood was withdrawn at the midpoint of each urine collection. CrCl at each timepoint was calculated according to the formula:

creatinine clearance (mL/minutes) = urine creatinine (mmol/L) x urine volume (mL) / serum creatinine (mmol/L) x time of collection (minutes) An average was to be calculated from the two 60 minute values in each interval.

ITT population. The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

mL/min

1-3 and 10-12 hours post allograft reperfusion

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Units	Counts
Participants	OG00024 OG00123 OG00226

Title

Denominators

Categories

1-3 hours post-transplant

- ParticipantsOG00021
- ParticipantsOG00120
- ParticipantsOG00223

Title	Measurements

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 OG002	This analysis refers to the 1-3 hours time point	Other		0.9076		Difference between means	-0.275			2-Sided	95	-5.00	4.45					Superiority	The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.
OG001 OG002

Secondary

Renal Function Tests - Serum Creatinine

Serum creatinine (SrCr) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

mmol/L

daily up to day 7 post-transplant or hospital discharge

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Renal Function Tests - Calculated Glomerular Filtration Rate

Calculated glomerular filtration rate (GFR) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

mL/min

from Day 1 up to 7 days post-transplant or up to hospital discharge

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Renal Function Tests - Urine Output

Urine output, measured in the interval from transplant to 8:00 of Day 1, and then daily from Day 2 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

from Day 1 up to 7 days post-transplant or up to hospital discharge

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Number of Patients Requiring Dialysis Within 7 Days Post-transplant

The number of patients who required dialysis within 7 days post-transplant was evaluated.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Count of Participants

Participants

up to day 7 post-transplant

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Number of Days on Dialysis Before Resuming Kidney Function

the number of days on dialysis before resuming kidney function was evaluated.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

days

up to Day 7 post-transplant

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Number of Patients With Immediate, Slow and Delayed Graft Function

The number of patients who required dialysis within 7 days post-transplant was evaluated.

Immediate graft function: SrCr ≤3 mg/dL on post operative day 5) Slow graft function: SrCr >3 mg/dL dL on post operative day 5, no need of dialysis) Delayed graft function: Dialysis needed in the first week)

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Count of Participants

Participants

day 5 post-transplant

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Duration of Hospital Stay

The mean duration of hospital stay was evaluated.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

days

first 30 days post-transplant

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Mortality

Mortality in the first 30 days post-transplant was evaluated.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Count of Participants

Participants

first 30 days post-transplant

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Serum Creatinine at Month 1, Month 6 and Month 12

Serum creatinine (SrCr) was measured at Month 1, Month 6 and Month 12.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

mmo/L

at Month 1, Month 6 and Month 12

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12

Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a rapid and cost-effective method for the measurement of renal function.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Mean

Standard Deviation

mL/min

at Month 1, Month 6 and Month 12

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12

Acute rejection defined as an increase in serum creatinine level after exclusion of other causes of graft dysfunction, accompanied by a sudden decline in glomerular filtration rate and renal function and well-established diagnostic features on kidney allograft biopsy which can be either antibody-mediated and/or T cell-mediated and can occur at any time after transplant.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Number

episodes

at Month 6 and between Month 6 and Month 12

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion

Secondary

Patient Survival Rate

Numbers of patients alive, dead, and lost to follow up are reported.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Count of Participants

Participants

at Month 1, Month 6 and Month 12

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Secondary

Graft Survival Rate

Graft failure was defined as the failure of graft function for any reason, ultimately requiring renal replacement therapy and/or retransplantation (United States Renal Data System [USRDS] 2017.

The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.

Posted

Number

number of grafts

at Month 1, Month 6 and Month 12

ID	Title	Description
OG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.
OG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
OG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment	EG0006 events6 affected25 at risk EG00110 events10 affected23 at risk EG00212 events12 affected26 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
PALPITATIONS	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
BLEPHARITIS	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0008 events8 affected25 at risk EG0015 events5 affected23 at risk EG0026 events6 affected26 at risk
VOMITING	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0005 events5 affected25 at risk EG0011 events1 affected23 at risk EG0024 events4 affected26 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0013 events3 affected23 at risk EG0022 events2 affected26 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected23 at risk EG0022 events2 affected26 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected23 at risk EG0020 events0 affected26 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
ILEUS	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PYREXIA	General disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected23 at risk EG0024 events4 affected26 at risk
OEDEMA	General disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
CHEST PAIN	General disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected23 at risk EG0020 events0 affected26 at risk
HAEMORRHAGIC CYST	General disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
PAIN	General disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
KIDNEY TRANSPLANT REJECTION	Immune system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected23 at risk EG0021 events1 affected26 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0015 events5 affected23 at risk EG0022 events2 affected26 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
BACTERIAL PYELONEPHRITIS	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
INFECTION	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PNEUMONIA	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
SEPSIS	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
WOUND INFECTION	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
COMPLICATIONS OF TRANSPLANTED KIDNEY	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected23 at risk EG0020 events0 affected26 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected23 at risk EG0021 events1 affected26 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
FEMORAL NERVE INJURY	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
GRAFT COMPLICATION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
INCISION SITE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
OPERATIVE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
PERINEPHRIC COLLECTION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PERIRENAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
POSTOPERATIVE WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
RENAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
THERAPEUTIC AGENT TOXICITY	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
URINARY ANASTOMOTIC LEAK	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
BLOOD PHOSPHORUS INCREASED	Investigations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0022 events2 affected26 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0021 events1 affected26 at risk
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
BLOOD AMYLASE INCREASED	Investigations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
BLOOD UREA INCREASED	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
ELECTROCARDIOGRAM T WAVE INVERSION	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0006 events6 affected25 at risk EG0013 events3 affected23 at risk EG0024 events4 affected26 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0016 events6 affected23 at risk EG0023 events3 affected26 at risk
ACIDOSIS	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0012 events2 affected23 at risk EG0025 events5 affected26 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0012 events2 affected23 at risk EG0024 events4 affected26 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected23 at risk EG0023 events3 affected26 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected23 at risk EG0023 events3 affected26 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0003 events3 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected23 at risk EG0021 events1 affected26 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0012 events2 affected23 at risk EG0020 events0 affected26 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
INSOMNIA	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0003 events3 affected25 at risk EG0012 events2 affected23 at risk EG0023 events3 affected26 at risk
ANXIETY	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected23 at risk EG0022 events2 affected26 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0005 events5 affected25 at risk EG0017 events7 affected23 at risk EG0027 events7 affected26 at risk
BLADDER SPASM	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0012 events2 affected23 at risk EG0021 events1 affected26 at risk
ANURIA	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected23 at risk EG0021 events1 affected26 at risk
RENAL VEIN THROMBOSIS	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0023 events3 affected26 at risk
URETERIC FISTULA	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected23 at risk EG0021 events1 affected26 at risk
DYSURIA	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
RENAL INFARCT	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
BLADDER PAIN	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
HAEMORRHAGE URINARY TRACT	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
OLIGURIA	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
RENAL TUBULAR DISORDER	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
URETERAL NECROSIS	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
URINARY BLADDER ATROPHY	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
URINOMA	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
SCROTAL OEDEMA	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
TESTICULAR PAIN	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected23 at risk EG0020 events0 affected26 at risk
COMPLICATIONS OF TRANSPLANTED KIDNEY	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0003 events3 affected25 at risk EG0010 events0 affected23 at risk EG0024 events4 affected26 at risk
RENAL ARTERY THROMBOSIS	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected23 at risk EG0022 events2 affected26 at risk
BRADYPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
OBSTRUCTIVE AIRWAYS DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
HYPOTENSION	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0006 events6 affected25 at risk EG0015 events5 affected23 at risk EG0023 events3 affected26 at risk
HYPERTENSION	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0011 events1 affected23 at risk EG0022 events2 affected26 at risk
RETROPERITONEAL HAEMORRHAGE	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
AORTIC ATHEROSCLEROSIS	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
ARTERIOVENOUS FISTULA THROMBOSIS	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected23 at risk EG0020 events0 affected26 at risk
HAEMODYNAMIC INSTABILITY	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected23 at risk EG0020 events0 affected26 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk
WOUND HAEMORRHAGE	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected23 at risk EG0021 events1 affected26 at risk

ID	Term
D015427	Reperfusion Injury
D007674	Kidney Diseases

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Reparixin Continuous Infusion	Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours.	0	25	12	25	24	25
EG001	Reparixin Intermittent Infusion	Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.	0	23	5	23	23	23
EG002	Placebo Continuous/Intermittent Infusion	Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.	1	26	9	26	25	26