Study Comparing Effect On Carotid Atherosclerosis Followi... | NCT00311311

Label	Type	Description	Intervention Names
1	Active Comparator	Tacrolimus + MMF + Steroids	Drug: tacrolimus Drug: mycophenolate mofetil Drug: prednisone
2	Experimental	Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant	Drug: sirolimus Drug: tacrolimus Drug: mycophenolate mofetil Drug: prednisone

Name	Type	Description	Arm Group Labels	Other Names
tacrolimus	Drug	The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.

Measure	Description	Time Frame
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant	Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.	Pre-conversion baseline and 12 months post-transplant
TPV at Pre-conversion Baseline	TPV is the sum of the assessment in left and right distal common carotid arteries.	Pre-conversion baseline

Measure	Description	Time Frame
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant	Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.	Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Rochester	New York	14642	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter [ng/mL] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to [>=] 500 milligram per day [mg/day]) or mycophenolate sodium (MPS) (>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.

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

Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.

On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant

Posted

Mean

Standard Deviation

millimeter cube/year (mmˆ3/year)

Pre-conversion baseline and 12 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Units	Counts
Participants	OG00018 OG00120

Title

Denominators

Categories

Title	Measurements
	OG000-49.31± 125.038 OG0010.66± 23.103

Primary

TPV at Pre-conversion Baseline

TPV is the sum of the assessment in left and right distal common carotid arteries.

On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline

Posted

Mean

Standard Deviation

mmˆ3

Pre-conversion baseline

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant

Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

millimeter/year (mm/year)

Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone

Secondary

CIMT at Pre-conversion Baseline

Mean CIMT=average of left CIMT and right CIMT.

On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline

Posted

Mean

Standard Deviation

Pre-conversion baseline

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant

Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.

Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.

Posted

Pre-conversion baseline, 12, and 24 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant

Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

millimole/liter (mmol/L)

Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone

Secondary

Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant

Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

mmol/L

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant

Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

picomole/liter (pmol/L)

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant

HbA1C, change = value at month x post-transplant - pre-conversion baseline.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point

Posted

Mean

Standard Deviation

percentage of glucose

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant

Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

microgram per milliliter (µg/mL)

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.

hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

mg/L

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant

TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

pg/mL

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant

Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Posted

Mean

Standard Deviation

pg/mL

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant

IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Posted

Mean

Standard Deviation

pg/mL

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant

Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Posted

Mean

Standard Deviation

micromole/liter (µmol/L)

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant

Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

milligram per deciliter (mg/dL)

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant

Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

gram per liter (g/L)

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant

Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points

Posted

Mean

Standard Deviation

pmol/L

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant

Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points

Posted

Mean

Standard Deviation

µmol/L

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant

Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.

Posted

Pre-conversion baseline, 12, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Number of Participants Who Used Lipid Lowering Therapies

Participants who reported "yes" for taking lipid lowering therapies as concomitant medication.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Posted

Number

participants

From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Number of Participants Who Used Anti-hypertensive Medications

Participants who reported "yes" for taking anti-hypertensive medications as concomitant medication.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Posted

Number

participants

From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.

Secondary

Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.

On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Posted

Mean

Standard Deviation

mmˆ3/year

Pre-conversion baseline, and 18, 24 and 36 months post-transplant

ID	Title	Description
OG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
OG001

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABDOMINAL PAIN	General disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0013 affected35 at risk
ACCIDENTAL INJURY	General disorders	COSTART 5.0	Non-systematic Assessment	EG0009 affected37 at risk EG0015 affected35 at risk
ASTHENIA	General disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0012 affected35 at risk
BACK PAIN	General disorders	COSTART 5.0	Non-systematic Assessment	EG0004 affected37 at risk EG0017 affected35 at risk
CHEST PAIN	General disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0011 affected35 at risk
FLU SYNDROME	General disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0014 affected35 at risk
HEADACHE	General disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0012 affected35 at risk
IMMUNE SYSTEM DISORDER	General disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0011 affected35 at risk
INFECTION	General disorders	COSTART 5.0	Non-systematic Assessment	EG0009 affected37 at risk EG0017 affected35 at risk
PAIN	General disorders	COSTART 5.0	Non-systematic Assessment	EG0007 affected37 at risk EG0017 affected35 at risk
VIRAL INFECTION	General disorders	COSTART 5.0	Non-systematic Assessment	EG0004 affected37 at risk EG0017 affected35 at risk
ARTERIOSCLEROSIS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
HYPERTENSION	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0012 affected35 at risk
HYPOTENSION	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
APHTHOUS STOMATITIS	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
CONSTIPATION	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0006 affected37 at risk EG0013 affected35 at risk
DIARRHEA	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0015 affected35 at risk
FLATULENCE	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0011 affected35 at risk
GASTROENTERITIS	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
NAUSEA	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0012 affected35 at risk
STOMATITIS	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0004 affected37 at risk EG0010 affected35 at risk
VOMITING	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0012 affected35 at risk
ANEMIA	Blood and lymphatic system disorders	COSTART 5.0	Non-systematic Assessment	EG0004 affected37 at risk EG0017 affected35 at risk
LEUKOPENIA	Blood and lymphatic system disorders	COSTART 5.0	Non-systematic Assessment	EG0006 affected37 at risk EG0012 affected35 at risk
AVITAMINOSIS	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
CREATININE INCREASED	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0017 affected35 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0013 affected35 at risk
EDEMA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0012 affected35 at risk
GLUCOSE TOLERANCE DECREASED	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
HYPERCALCEMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0015 affected35 at risk
HYPERCHOLESTEREMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0009 affected37 at risk EG0012 affected35 at risk
HYPERLIPEMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG00014 affected37 at risk EG0015 affected35 at risk
PERIPHERAL EDEMA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG00013 affected37 at risk EG0016 affected35 at risk
WEIGHT GAIN	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0016 affected35 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0007 affected37 at risk EG0014 affected35 at risk
ARTHROSIS	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
BONE DISORDER	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0013 affected35 at risk
JOINT DISORDER	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
INSOMNIA	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0013 affected35 at risk
PARESTHESIA	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0013 affected35 at risk
COUGH INCREASED	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0013 affected35 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0013 affected35 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0007 affected37 at risk EG0016 affected35 at risk
RHINITIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0014 affected35 at risk
ACNE	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0012 affected35 at risk
HERPES ZOSTER	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0011 affected35 at risk
PRURITUS	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0012 affected35 at risk
RASH	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0007 affected37 at risk EG0013 affected35 at risk
SKIN BENIGN NEOPLASM	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0014 affected35 at risk
SKIN DISORDER	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0004 affected37 at risk EG0011 affected35 at risk
SKIN HYPERTROPHY	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0013 affected35 at risk
SWEATING	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
CONJUNCTIVITIS	Eye disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
ALBUMINURIA	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0009 affected37 at risk EG0012 affected35 at risk
HEMATURIA	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0005 affected37 at risk EG0014 affected35 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0004 affected37 at risk EG0015 affected35 at risk
FEVER	General disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
LAB TEST ABNORMAL	General disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
DEEP THROMBOPHLEBITIS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0010 affected35 at risk
ANOREXIA	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
DYSPEPSIA	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0013 affected35 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
PARATHYROID DISORDER	Endocrine disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
POLYCYTHEMIA	Blood and lymphatic system disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0013 affected35 at risk
HYPERKALEMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0013 affected35 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0010 affected35 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
ANXIETY	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
DIZZINESS	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0014 affected35 at risk
BRONCHITIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
HERPES SIMPLEX	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
DYSURIA	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
UREMIA	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
URINARY INCONTINENCE	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
HEALING ABNORMAL	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0003 affected37 at risk EG0010 affected35 at risk
PNEUMONIA	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
BG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone	Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.			17	37	36	37
EG001	Tacrolimus With Mycophenolate/Prednisone	Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.			21	35	33	35

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CARCINOMA	General disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0011 affected35 at risk
CELLULITIS	General disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
CHEST PAIN	General disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0011 affected35 at risk
FEVER	General disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
HERNIA	General disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
IMMUNE SYSTEM DISORDER	General disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0012 affected35 at risk
INFECTION	General disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0013 affected35 at risk
SEPSIS	General disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0011 affected35 at risk
VIRAL INFECTION	General disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0012 affected35 at risk
ARTERIOSCLEROSIS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
CORONARY ARTERY DISORDER	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
EMBOLUS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
MYOCARDIAL INFARCT	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0011 affected35 at risk
PERIPHERAL VASCULAR DISORDER	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
THROMBOPHLEBITIS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
THROMBOSIS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
ESOPHAGITIS	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
GASTROINTESTINAL HEMORRHAGE	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
HEPATITIS	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
NAUSEA	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
VOMITING	Gastrointestinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
LEUKOPENIA	Blood and lymphatic system disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0011 affected35 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
HYPONATREMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
BONE DISORDER	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
BONE NECROSIS	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
CEREBRAL ISCHEMIA	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
NEUROPATHY	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
PARAPLEGIA	Nervous system disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
HEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
PNEUMONIA	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
SINUSITIS	Respiratory, thoracic and mediastinal disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
ACUTE KIDNEY FAILURE	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
KIDNEY FAILURE	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
KIDNEY FUNCTION ABNORMAL	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
PROSTATIC CARCINOMA	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
PYELONEPHRITIS	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0002 affected37 at risk EG0012 affected35 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0012 affected35 at risk
ACCIDENTAL INJURY	General disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0010 affected35 at risk
INFECTION BACTERIAL	General disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0011 affected35 at risk
VASCULAR ANOMALY	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
HYPOCALCEMIA	Metabolism and nutrition disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
ARTHROSIS	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
OSTEOMYELITIS	Musculoskeletal and connective tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
SKIN CARCINOMA	Skin and subcutaneous tissue disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
ANGINA PECTORIS	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0012 affected35 at risk
ATRIAL FIBRILLATION	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0000 affected37 at risk EG0011 affected35 at risk
Congestive Heart Failure	Cardiac disorders	COSTART 5.0	Non-systematic Assessment	EG0001 affected37 at risk EG0011 affected35 at risk

ID	Term
D016559	Tacrolimus
D009173	Mycophenolic Acid
D011241	Prednisone
D020123	Sirolimus