Trial Outcomes & Findings for A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients (NCT NCT00106639)

Last Updated: 2013-03-12

Results Overview

BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Baseline up to Month 6

Results posted on

2013-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 15 mg CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Overall Study STARTED	20	20	21
Overall Study COMPLETED	17	13	19
Overall Study NOT COMPLETED	3	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 15 mg CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Overall Study Adverse Event	3	4	1
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	0	1	0
Overall Study Participant defaulted	0	1	1

Baseline Characteristics

A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.	Total n=61 Participants Total of all reporting groups
Age Continuous	46.9 years STANDARD_DEVIATION 8.5 • n=5 Participants	44.3 years STANDARD_DEVIATION 12.3 • n=7 Participants	42.8 years STANDARD_DEVIATION 11.8 • n=5 Participants	44.6 years STANDARD_DEVIATION 11.0 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to Month 6

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.

BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6	1 participants	4 participants	1 participants

PRIMARY outcome

Timeframe: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies those participants evaluable for this measure.

GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\*body weight) minus (0.5\*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is \>90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=17 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=14 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=18 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6	76.53 mL/min Standard Deviation 10.04	71.50 mL/min Standard Deviation 14.68	78.70 mL/min Standard Deviation 12.61

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Treatment failure was defined as the first occurrence of BPAR, graft loss, participant's death or premature discontinuation of study medication for any reason.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Treatment Failure Month 3	1 participants	7 participants	2 participants
Number of Participants With Treatment Failure Month 6	3 participants	9 participants	3 participants

SECONDARY outcome

Timeframe: Baseline up to Month 3

Population: FAS included all randomized participants who received at least 1 dose of study medication.

BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3	0 participants	4 participants	1 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) Month 3	0 participants	0 participants	0 participants
Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) Month 6	0 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 3: IA	0 participants	1 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 3: IB	0 participants	0 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 3: IIA	0 participants	2 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 3: IIB	0 participants	1 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 6: IA	0 participants	1 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 6: IIA	1 participants	2 participants	1 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 3: III	0 participants	0 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 6: IB	0 participants	0 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 6: IIB	0 participants	1 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) Month 6: III	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) Month 3: Any severity	0 participants	0 participants	0 participants
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) Month 6: I	0 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Efficacy Failure Month 3	0 participants	4 participants	1 participants
Number of Participants With Efficacy Failure Month 6	1 participants	4 participants	1 participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (\>=) 6 consecutive weeks.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Graft Loss	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants Who Died	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Rejection Month 3	1 participants	4 participants	1 participants
Number of Participants With Rejection Month 6	2 participants	4 participants	1 participants

SECONDARY outcome

Timeframe: Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies those participants evaluable at specific time points for each arm group respectively.

The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells\*10\^3 per cubic millimeter (cells\*10\^3/mm\^3).

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Reticulocyte Count Month 6 (n= 16, 14, 18)	79.81 cells*10^3/mm^3 Standard Deviation 43.02	73.07 cells*10^3/mm^3 Standard Deviation 12.46	71.89 cells*10^3/mm^3 Standard Deviation 30.85
Reticulocyte Count Baseline (n= 20, 20, 21)	81.75 cells*10^3/mm^3 Standard Deviation 58.39	68.50 cells*10^3/mm^3 Standard Deviation 30.40	75.67 cells*10^3/mm^3 Standard Deviation 38.96
Reticulocyte Count Day 14 (n= 18, 19, 18)	93.06 cells*10^3/mm^3 Standard Deviation 50.13	109.47 cells*10^3/mm^3 Standard Deviation 73.60	81.61 cells*10^3/mm^3 Standard Deviation 39.43
Reticulocyte Count Month 1 (n= 19, 18, 19)	94.37 cells*10^3/mm^3 Standard Deviation 31.58	87.39 cells*10^3/mm^3 Standard Deviation 33.55	101.37 cells*10^3/mm^3 Standard Deviation 50.30
Reticulocyte Count Month 3 (n= 19, 17, 20)	83.00 cells*10^3/mm^3 Standard Deviation 41.52	90.94 cells*10^3/mm^3 Standard Deviation 31.64	85.90 cells*10^3/mm^3 Standard Deviation 30.19

SECONDARY outcome

Timeframe: Pre-dose on Day 14, Month 1, 3, 6

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=18 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Trough Levels of Tacrolimus (TAC) Day 14 (n= 18)	11.17 nanogram/milliliter (ng/mL) Standard Deviation 4.15	—	—
Trough Levels of Tacrolimus (TAC) Month 1 (n= 18)	9.11 nanogram/milliliter (ng/mL) Standard Deviation 3.20	—	—
Trough Levels of Tacrolimus (TAC) Month 3 (n= 17)	8.82 nanogram/milliliter (ng/mL) Standard Deviation 4.05	—	—
Trough Levels of Tacrolimus (TAC) Month 6 (n= 15)	8.33 nanogram/milliliter (ng/mL) Standard Deviation 4.06	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=16 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=17 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=17 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Physical functioning: Baseline (n= 16, 17, 17)	47.30 units on a scale Standard Deviation 8.31	43.79 units on a scale Standard Deviation 12.69	41.20 units on a scale Standard Deviation 13.43
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Role emotional: Baseline (n= 16, 17, 17)	41.06 units on a scale Standard Deviation 17.34	37.81 units on a scale Standard Deviation 16.20	39.64 units on a scale Standard Deviation 15.26
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Role emotional: Month 6 (n= 15, 10, 17)	48.36 units on a scale Standard Deviation 12.51	52.77 units on a scale Standard Deviation 8.56	49.70 units on a scale Standard Deviation 13.33
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Role physical: Baseline (n= 16, 17, 17)	38.64 units on a scale Standard Deviation 12.74	36.69 units on a scale Standard Deviation 12.35	33.66 units on a scale Standard Deviation 8.84
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Social functioning: Baseline (n= 16, 17, 17)	39.46 units on a scale Standard Deviation 13.24	41.45 units on a scale Standard Deviation 10.95	42.73 units on a scale Standard Deviation 10.75
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Bodily pain: Baseline (n= 16, 17, 17)	49.89 units on a scale Standard Deviation 10.55	52.15 units on a scale Standard Deviation 10.91	50.46 units on a scale Standard Deviation 11.14
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Bodily pain: Month 6 (n=15, 10, 17)	54.79 units on a scale Standard Deviation 10.30	55.06 units on a scale Standard Deviation 8.77	57.54 units on a scale Standard Deviation 8.93
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) General health: Baseline (n= 15, 17, 17)	44.48 units on a scale Standard Deviation 10.72	43.40 units on a scale Standard Deviation 9.47	43.65 units on a scale Standard Deviation 7.46
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) General health: Month 6 (n= 15, 10, 17)	49.79 units on a scale Standard Deviation 8.12	49.50 units on a scale Standard Deviation 6.71	53.80 units on a scale Standard Deviation 8.85
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Mental CS: Baseline (n= 15, 17, 17)	45.18 units on a scale Standard Deviation 13.79	42.15 units on a scale Standard Deviation 12.20	46.73 units on a scale Standard Deviation 8.40
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Mental CS: Month 6 (n= 15, 10, 17)	52.38 units on a scale Standard Deviation 11.18	56.18 units on a scale Standard Deviation 5.22	51.62 units on a scale Standard Deviation 9.11
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Mental health: Baseline (n= 16, 17, 17)	47.90 units on a scale Standard Deviation 11.84	46.53 units on a scale Standard Deviation 10.79	49.68 units on a scale Standard Deviation 7.64
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Mental health: Month 6 (n= 15, 10, 17)	52.82 units on a scale Standard Deviation 11.16	54.51 units on a scale Standard Deviation 5.97	51.17 units on a scale Standard Deviation 8.45
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Physical CS: Baseline (n= 15, 17, 17)	45.37 units on a scale Standard Deviation 8.60	44.71 units on a scale Standard Deviation 10.76	41.11 units on a scale Standard Deviation 9.76
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Physical CS: Month 6 (n= 15, 10, 17)	50.67 units on a scale Standard Deviation 8.98	49.76 units on a scale Standard Deviation 6.31	53.87 units on a scale Standard Deviation 8.87
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Physical functioning: Month 6 (n= 15, 10, 17)	47.49 units on a scale Standard Deviation 12.03	48.40 units on a scale Standard Deviation 7.58	50.72 units on a scale Standard Deviation 10.28
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Q2: Baseline (n= 16, 17, 17)	3.25 units on a scale Standard Deviation 1.24	3.18 units on a scale Standard Deviation 1.33	2.59 units on a scale Standard Deviation 1.06
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Q2: Month 6 (n= 15, 10, 17)	1.07 units on a scale Standard Deviation 0.26	1.10 units on a scale Standard Deviation 0.32	1.41 units on a scale Standard Deviation 1.06
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Role physical: Month 6 (n= 15, 10, 17)	51.14 units on a scale Standard Deviation 8.81	50.73 units on a scale Standard Deviation 9.25	50.51 units on a scale Standard Deviation 11.09
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Social functioning: Month 6 (n= 15, 10, 17)	51.03 units on a scale Standard Deviation 8.36	53.58 units on a scale Standard Deviation 5.27	50.75 units on a scale Standard Deviation 9.62
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Vitality: Baseline (n= 16, 17, 17)	46.43 units on a scale Standard Deviation 12.55	43.46 units on a scale Standard Deviation 11.12	46.77 units on a scale Standard Deviation 9.29
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Vitality: Month 6 (n= 15, 10, 17)	56.25 units on a scale Standard Deviation 10.66	58.65 units on a scale Standard Deviation 4.76	58.52 units on a scale Standard Deviation 10.73

SECONDARY outcome

Timeframe: Baseline, Month 6

ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated question"At the moment,how much do you suffer?"for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=15 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=15 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=17 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) Cardiac and renal dysfunction:Baseline(n=13,15,17)	0.60 units on a scale Standard Deviation 0.43	0.78 units on a scale Standard Deviation 0.68	0.67 units on a scale Standard Deviation 0.60
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) Limited cognitive capacity: Baseline (n=14,15,17)	0.68 units on a scale Standard Deviation 0.65	0.58 units on a scale Standard Deviation 0.69	0.78 units on a scale Standard Deviation 0.57
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) Limited physical capacity: Baseline (n=14,15,17)	0.65 units on a scale Standard Deviation 0.46	0.77 units on a scale Standard Deviation 0.57	0.62 units on a scale Standard Deviation 0.35
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) Limited physical capacity: Month 6 (n=15,10,16)	0.41 units on a scale Standard Deviation 0.39	0.49 units on a scale Standard Deviation 0.48	0.38 units on a scale Standard Deviation 0.53
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) SEs of corticosteroids: Month 6 (n=15,10,16)	0.65 units on a scale Standard Deviation 0.78	0.52 units on a scale Standard Deviation 0.48	0.24 units on a scale Standard Deviation 0.43
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) TAPD: Baseline (n=14,15,17)	1.10 units on a scale Standard Deviation 0.68	1.14 units on a scale Standard Deviation 0.78	0.97 units on a scale Standard Deviation 0.47
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) Cardiac and renal dysfunction:Month 6(n=15,10,16)	0.26 units on a scale Standard Deviation 0.27	0.30 units on a scale Standard Deviation 0.32	0.22 units on a scale Standard Deviation 0.28
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) In growth of gum and hair: Baseline (n=14,15,17)	0.19 units on a scale Standard Deviation 0.36	0.11 units on a scale Standard Deviation 0.15	0.13 units on a scale Standard Deviation 0.26
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) In growth of gum and hair: Month 6 (n=15,9,16)	0.17 units on a scale Standard Deviation 0.27	0.11 units on a scale Standard Deviation 0.15	0.10 units on a scale Standard Deviation 0.22
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) Limited cognitive capacity: Month 6 (n=15,10,17))	0.55 units on a scale Standard Deviation 0.49	0.16 units on a scale Standard Deviation 0.31	0.35 units on a scale Standard Deviation 0.46
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) SEs of corticosteroids: Baseline (n=13,15,17)	0.58 units on a scale Standard Deviation 0.64	0.44 units on a scale Standard Deviation 0.51	0.68 units on a scale Standard Deviation 0.74
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) TAPD: Month 6 (n=15,10,16)	0.69 units on a scale Standard Deviation 0.44	0.51 units on a scale Standard Deviation 0.36	0.58 units on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline, Month 6

Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=16 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=16 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=17 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Healthcare Resource Utilization Questionnaire (HCRUQ) Diagnostic tests: Baseline (n= 14, 16, 17)	7.14 events Standard Deviation 8.56	5.88 events Standard Deviation 6.06	16.06 events Standard Deviation 28.45
Healthcare Resource Utilization Questionnaire (HCRUQ) Physician visits: Baseline (n= 15, 16, 17)	3.33 events Standard Deviation 4.15	4.31 events Standard Deviation 4.74	4.47 events Standard Deviation 6.32
Healthcare Resource Utilization Questionnaire (HCRUQ) Physician visits: Month 6 (n= 10, 7, 10)	4.20 events Standard Deviation 6.34	7.29 events Standard Deviation 8.88	8.70 events Standard Deviation 8.63
Healthcare Resource Utilization Questionnaire (HCRUQ) Emergency room visits: Baseline (n= 16, 16, 17)	0.06 events Standard Deviation 0.25	0.19 events Standard Deviation 0.40	0.00 events Standard Deviation 0.00
Healthcare Resource Utilization Questionnaire (HCRUQ) Emergency room visits: Month 6 (n= 10, 7, 10)	0.50 events Standard Deviation 0.85	0.14 events Standard Deviation 0.38	0.10 events Standard Deviation 0.32
Healthcare Resource Utilization Questionnaire (HCRUQ) Diagnostic tests: Month 6 (n= 10, 7, 10)	0.40 events Standard Deviation 0.97	0.86 events Standard Deviation 1.21	4.20 events Standard Deviation 12.25
Healthcare Resource Utilization Questionnaire (HCRUQ) Hospital visits: Baseline (n= 15, 16, 17)	0.07 events Standard Deviation 0.26	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00
Healthcare Resource Utilization Questionnaire (HCRUQ) Hospital visits: Month 6 (n= 10, 7, 10)	0.60 events Standard Deviation 1.07	0.43 events Standard Deviation 0.79	0.10 events Standard Deviation 0.32

SECONDARY outcome

Timeframe: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure.

Fifth question in the HCRUQ was "Upon discharge from the hospital, did you return to your previous place of residence?" and number of participants who responded "yes or no" to the question was reported.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=9 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=6 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=7 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question No	2 participants	0 participants	1 participants
Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question Yes	7 participants	6 participants	6 participants

SECONDARY outcome

Timeframe: Day 14, Month 1, 3, 6

GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight\*(140 minus age in years) divided by (72\*serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Glomerular Filtration Rate (GFR) by Cockcroft-Gault Day 14 (n= 19, 19, 20)	73.24 mL/min Standard Deviation 19.14	78.37 mL/min Standard Deviation 20.08	76.14 mL/min Standard Deviation 17.14
Glomerular Filtration Rate (GFR) by Cockcroft-Gault Month 1 (n= 20, 18, 19)	80.73 mL/min Standard Deviation 23.47	81.83 mL/min Standard Deviation 11.54	79.90 mL/min Standard Deviation 19.15
Glomerular Filtration Rate (GFR) by Cockcroft-Gault Month 3 (n= 18, 18, 20)	81.84 mL/min Standard Deviation 15.81	81.99 mL/min Standard Deviation 14.95	86.86 mL/min Standard Deviation 20.03
Glomerular Filtration Rate (GFR) by Cockcroft-Gault Month 6 (n= 17, 14, 18)	82.17 mL/min Standard Deviation 19.27	79.99 mL/min Standard Deviation 19.72	91.89 mL/min Standard Deviation 16.66

SECONDARY outcome

Timeframe: Day 14, Month 1, 3, 6

GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 \* (serum creatinine) \^ (-0.999)\*(age in years)\^(-0.176)\*(0.762 if female) \* (1.18 if black)\*(blood urea nitrogen concentration)\^(-0.170)\*(serum albumin concentration)\^(0.318). Normal GFR is \>90 mL/min/1.73 square meter (m\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation Month 1 (n= 20, 18, 19)	66.82 mL/min/1.73 m^2 Standard Deviation 20.83	62.70 mL/min/1.73 m^2 Standard Deviation 9.50	62.55 mL/min/1.73 m^2 Standard Deviation 22.47
Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation Month 3 (n= 18, 18, 20)	64.58 mL/min/1.73 m^2 Standard Deviation 13.68	62.04 mL/min/1.73 m^2 Standard Deviation 12.46	66.45 mL/min/1.73 m^2 Standard Deviation 22.00
Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation Month 6 (n= 17, 14, 18)	63.59 mL/min/1.73 m^2 Standard Deviation 12.02	58.95 mL/min/1.73 m^2 Standard Deviation 16.19	68.29 mL/min/1.73 m^2 Standard Deviation 22.10
Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation Day 14 (n= 19, 19, 20)	60.67 mL/min/1.73 m^2 Standard Deviation 19.01	57.97 mL/min/1.73 m^2 Standard Deviation 16.32	56.70 mL/min/1.73 m^2 Standard Deviation 21.39

SECONDARY outcome

Timeframe: Day 14, Month 1, 3, 6

GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) Month 1 (n= 20, 18, 19)	0.91 deciliter/mg (dL/mg) Standard Deviation 0.30	0.79 deciliter/mg (dL/mg) Standard Deviation 0.14	0.78 deciliter/mg (dL/mg) Standard Deviation 0.24
Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) Day 14 (n= 19, 19, 20)	0.87 deciliter/mg (dL/mg) Standard Deviation 0.28	0.75 deciliter/mg (dL/mg) Standard Deviation 0.19	0.75 deciliter/mg (dL/mg) Standard Deviation 0.24
Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) Month 3 (n= 18, 18, 20)	0.86 deciliter/mg (dL/mg) Standard Deviation 0.21	0.77 deciliter/mg (dL/mg) Standard Deviation 0.18	0.82 deciliter/mg (dL/mg) Standard Deviation 0.21
Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) Month 6 (n= 17, 14, 18)	0.86 deciliter/mg (dL/mg) Standard Deviation 0.19	0.73 deciliter/mg (dL/mg) Standard Deviation 0.19	0.84 deciliter/mg (dL/mg) Standard Deviation 0.19

SECONDARY outcome

Timeframe: Baseline up to Month 8 (2 months follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	20 participants	18 participants	21 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	8 participants	10 participants	6 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With First Clinically Significant Infection Month 3	2 participants	7 participants	3 participants
Number of Participants With First Clinically Significant Infection Month 6	6 participants	11 participants	5 participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With New Onset Diabetes Mellitus (NODM) Month 3	0 participants	0 participants	2 participants
Number of Participants With New Onset Diabetes Mellitus (NODM) Month 6	1 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Fasting Serum Glucose Levels Baseline: (n= 18, 19, 21)	114.50 mg/dL Standard Deviation 63.72	102.68 mg/dL Standard Deviation 63.26	90.29 mg/dL Standard Deviation 19.87
Fasting Serum Glucose Levels Day 14 (n= 19, 19, 20)	131.58 mg/dL Standard Deviation 85.36	95.58 mg/dL Standard Deviation 32.45	99.85 mg/dL Standard Deviation 32.43
Fasting Serum Glucose Levels Month 6 (n= 17, 14, 18)	108.76 mg/dL Standard Deviation 36.78	94.57 mg/dL Standard Deviation 19.41	95.11 mg/dL Standard Deviation 22.68
Fasting Serum Glucose Levels Month 1 (n= 20, 18, 19)	120.35 mg/dL Standard Deviation 90.42	85.22 mg/dL Standard Deviation 18.40	99.16 mg/dL Standard Deviation 29.37
Fasting Serum Glucose Levels Month 3 (n= 18, 18, 20)	93.56 mg/dL Standard Deviation 21.94	92.56 mg/dL Standard Deviation 34.75	101.05 mg/dL Standard Deviation 22.79

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Hypercholesterolemia Baseline (n= 18, 19, 21)	1 participants	1 participants	0 participants
Number of Participants With Hypercholesterolemia Day 14 (n= 19, 19, 20)	5 participants	5 participants	1 participants
Number of Participants With Hypercholesterolemia Month 1 (n= 20, 18, 19)	8 participants	6 participants	2 participants
Number of Participants With Hypercholesterolemia Month 3 (n= 18, 18, 20)	5 participants	5 participants	2 participants
Number of Participants With Hypercholesterolemia Month 6 (n= 17, 14, 18)	4 participants	3 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels Total serum cholesterol: Baseline (n=18,19,21)	168.78 mg/dL Standard Deviation 34.33	159.79 mg/dL Standard Deviation 39.20	166.86 mg/dL Standard Deviation 38.25
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels Total serum cholesterol: Day 14 (n=19,19,20)	217.21 mg/dL Standard Deviation 44.79	208.05 mg/dL Standard Deviation 56.37	184.95 mg/dL Standard Deviation 36.79
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels Total serum cholesterol: Month 1 (n=20,18,19)	245.20 mg/dL Standard Deviation 48.51	232.17 mg/dL Standard Deviation 66.17	202.89 mg/dL Standard Deviation 31.94
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels Total serum cholesterol: Month 3 (n=18,18,20)	216.17 mg/dL Standard Deviation 38.92	203.00 mg/dL Standard Deviation 49.34	193.90 mg/dL Standard Deviation 39.74
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels Total serum cholesterol: Month 6 (n=17,14,18)	207.88 mg/dL Standard Deviation 36.01	206.07 mg/dL Standard Deviation 38.72	195.50 mg/dL Standard Deviation 43.28
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels LDL: Baseline (n=18,18,19)	93.17 mg/dL Standard Deviation 28.08	87.78 mg/dL Standard Deviation 27.85	90.74 mg/dL Standard Deviation 31.76
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels LDL: Day 14 (n=17,19,20)	114.71 mg/dL Standard Deviation 36.60	113.05 mg/dL Standard Deviation 38.08	98.70 mg/dL Standard Deviation 25.81
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels LDL: Month 1 (n=18,18,19)	139.28 mg/dL Standard Deviation 35.85	130.50 mg/dL Standard Deviation 48.80	110.32 mg/dL Standard Deviation 26.78
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels LDL: Month 3 (n=18,18,20)	118.72 mg/dL Standard Deviation 33.15	114.06 mg/dL Standard Deviation 35.10	111.50 mg/dL Standard Deviation 34.87
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels LDL: Month 6 (n=17,14,18)	117.00 mg/dL Standard Deviation 27.20	119.00 mg/dL Standard Deviation 28.21	114.50 mg/dL Standard Deviation 36.61
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels HDL: Baseline (n=18,19,21)	43.89 mg/dL Standard Deviation 13.01	36.84 mg/dL Standard Deviation 12.76	46.00 mg/dL Standard Deviation 11.75
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels HDL: Day 14 (n=19,19,20)	61.58 mg/dL Standard Deviation 13.20	64.16 mg/dL Standard Deviation 16.54	55.05 mg/dL Standard Deviation 16.77
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels HDL: Month 1 (n=20,18,19)	75.65 mg/dL Standard Deviation 19.26	69.06 mg/dL Standard Deviation 21.29	62.16 mg/dL Standard Deviation 19.66
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels HDL: Month 3 (n=18,18,20)	66.17 mg/dL Standard Deviation 16.51	56.11 mg/dL Standard Deviation 17.88	54.05 mg/dL Standard Deviation 13.80
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels HDL: Month 6 (n=17,14,18)	59.53 mg/dL Standard Deviation 18.43	51.50 mg/dL Standard Deviation 12.78	55.00 mg/dL Standard Deviation 14.97

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Hypertriglyceridemia Baseline (n= 18, 19, 21)	4 participants	7 participants	5 participants
Number of Participants With Hypertriglyceridemia Day 14 (n= 19, 19, 20)	7 participants	2 participants	6 participants
Number of Participants With Hypertriglyceridemia Month 1 (n= 20, 18, 19)	7 participants	5 participants	3 participants
Number of Participants With Hypertriglyceridemia Month 3 (n= 18, 18, 20)	5 participants	5 participants	2 participants
Number of Participants With Hypertriglyceridemia Month 6 (n= 17, 14, 18)	5 participants	5 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Day 2, 3, 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Supine Systolic and Diastolic Blood Pressure (BP) DBP: Month 3 (n= 19, 18, 21)	80.42 millimeter of mercury Standard Deviation 10.91	76.06 millimeter of mercury Standard Deviation 12.66	77.33 millimeter of mercury Standard Deviation 10.88
Supine Systolic and Diastolic Blood Pressure (BP) DBP: Month 6 (n= 17, 13, 19)	77.24 millimeter of mercury Standard Deviation 10.46	83.23 millimeter of mercury Standard Deviation 10.21	79.00 millimeter of mercury Standard Deviation 9.99
Supine Systolic and Diastolic Blood Pressure (BP) Diastolic BP (DBP) : Baseline (n= 20, 20, 21)	77.10 millimeter of mercury Standard Deviation 14.04	75.25 millimeter of mercury Standard Deviation 9.95	76.52 millimeter of mercury Standard Deviation 17.71
Supine Systolic and Diastolic Blood Pressure (BP) DBP: Day 2 (n= 19, 20, 20)	79.05 millimeter of mercury Standard Deviation 13.62	80.20 millimeter of mercury Standard Deviation 9.68	78.50 millimeter of mercury Standard Deviation 10.37
Supine Systolic and Diastolic Blood Pressure (BP) DBP: Day 3 (n= 18, 19, 18)	82.50 millimeter of mercury Standard Deviation 10.59	88.05 millimeter of mercury Standard Deviation 9.45	82.61 millimeter of mercury Standard Deviation 9.67
Supine Systolic and Diastolic Blood Pressure (BP) DBP: Day 14 (n= 20, 19, 20)	78.45 millimeter of mercury Standard Deviation 11.83	81.21 millimeter of mercury Standard Deviation 8.15	75.20 millimeter of mercury Standard Deviation 7.29
Supine Systolic and Diastolic Blood Pressure (BP) DBP: Month 1 (n= 20, 18, 19)	78.95 millimeter of mercury Standard Deviation 11.08	80.83 millimeter of mercury Standard Deviation 9.29	76.32 millimeter of mercury Standard Deviation 11.61
Supine Systolic and Diastolic Blood Pressure (BP) Systolic BP (SBP): Baseline (n= 20, 20, 21)	139.65 millimeter of mercury Standard Deviation 23.22	139.45 millimeter of mercury Standard Deviation 18.98	136.24 millimeter of mercury Standard Deviation 27.68
Supine Systolic and Diastolic Blood Pressure (BP) SBP: Day 2 (n= 19, 20, 20)	141.16 millimeter of mercury Standard Deviation 18.66	143.55 millimeter of mercury Standard Deviation 13.87	136.05 millimeter of mercury Standard Deviation 20.14
Supine Systolic and Diastolic Blood Pressure (BP) SBP: Day 3 (n= 18, 19, 18)	146.78 millimeter of mercury Standard Deviation 17.33	152.42 millimeter of mercury Standard Deviation 14.47	139.94 millimeter of mercury Standard Deviation 18.13
Supine Systolic and Diastolic Blood Pressure (BP) SBP: Day 14 (n= 20, 19, 20)	135.90 millimeter of mercury Standard Deviation 24.43	141.16 millimeter of mercury Standard Deviation 19.48	121.45 millimeter of mercury Standard Deviation 17.01
Supine Systolic and Diastolic Blood Pressure (BP) SBP: Month 1 (n= 20, 18, 19)	129.05 millimeter of mercury Standard Deviation 19.06	136.22 millimeter of mercury Standard Deviation 15.01	128.21 millimeter of mercury Standard Deviation 13.57
Supine Systolic and Diastolic Blood Pressure (BP) SBP: Month 3 (n= 19, 18, 21)	140.32 millimeter of mercury Standard Deviation 20.58	133.44 millimeter of mercury Standard Deviation 20.05	124.00 millimeter of mercury Standard Deviation 14.65
Supine Systolic and Diastolic Blood Pressure (BP) SBP: Month 6 (n= 17, 13, 19)	135.76 millimeter of mercury Standard Deviation 17.08	134.31 millimeter of mercury Standard Deviation 14.82	128.00 millimeter of mercury Standard Deviation 17.94

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Drug Usage OHA, ADA, insulin usage: Month 6 (n= 18, 15, 20)	6 participants	3 participants	2 participants
Number of Participants With Drug Usage Lipid Lowering: Baseline ( n= 20, 20, 21)	6 participants	9 participants	9 participants
Number of Participants With Drug Usage Lipid Lowering: Day 14 (n= 20, 19, 21)	3 participants	4 participants	4 participants
Number of Participants With Drug Usage Lipid Lowering: Month 1 (n= 20, 19, 21)	5 participants	5 participants	4 participants
Number of Participants With Drug Usage Lipid Lowering: Month 3 (n= 20, 19, 20)	8 participants	9 participants	5 participants
Number of Participants With Drug Usage Lipid Lowering: Month 6 (n= 18, 15, 20)	10 participants	8 participants	7 participants
Number of Participants With Drug Usage Antihypertensive: Baseline ( n= 20, 20, 21)	17 participants	18 participants	18 participants
Number of Participants With Drug Usage Antihypertensive: Day 14 (n= 20, 19, 21)	15 participants	19 participants	15 participants
Number of Participants With Drug Usage Antihypertensive: Month 1 (n= 20, 19, 21)	15 participants	18 participants	16 participants
Number of Participants With Drug Usage Antihypertensive: Month 3 (n= 20, 19, 20)	16 participants	18 participants	17 participants
Number of Participants With Drug Usage Antihypertensive: Month 6 (n= 18, 15, 20)	14 participants	11 participants	16 participants
Number of Participants With Drug Usage OHA, ADA, insulin usage: Baseline (n= 20, 20, 21)	9 participants	7 participants	5 participants
Number of Participants With Drug Usage OHA, ADA, insulin usage: Day 14 (n= 20, 19, 21)	5 participants	4 participants	3 participants
Number of Participants With Drug Usage OHA, ADA, insulin usage: Month 1 (n= 20, 19, 21)	5 participants	4 participants	3 participants
Number of Participants With Drug Usage OHA, ADA, insulin usage: Month 3 (n= 20, 19, 20)	5 participants	4 participants	3 participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load CMV: Month 3 (n= 18, 18, 20)	55.67 Copies/500 ng DNA Standard Deviation 235.67	4.06 Copies/500 ng DNA Standard Deviation 16.71	0.05 Copies/500 ng DNA Standard Deviation 0.22
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load EBV: Baseline (n= 20, 19, 19)	2.65 Copies/500 ng DNA Standard Deviation 11.39	0.26 Copies/500 ng DNA Standard Deviation 0.81	3.21 Copies/500 ng DNA Standard Deviation 11.27
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load EBV: Day 14 (n= 18, 19, 20)	4.22 Copies/500 ng DNA Standard Deviation 13.82	0.58 Copies/500 ng DNA Standard Deviation 0.90	3.60 Copies/500 ng DNA Standard Deviation 9.32
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load EBV: Month 1 (n= 20, 18, 18)	5.25 Copies/500 ng DNA Standard Deviation 20.97	0.50 Copies/500 ng DNA Standard Deviation 0.92	1.94 Copies/500 ng DNA Standard Deviation 5.23
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load EBV: Month 3 (n= 18, 18, 20)	0.28 Copies/500 ng DNA Standard Deviation 0.57	0.28 Copies/500 ng DNA Standard Deviation 0.46	0.65 Copies/500 ng DNA Standard Deviation 1.95
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load EBV: Month 6 (n= 15, 13, 18)	0.73 Copies/500 ng DNA Standard Deviation 1.79	15.15 Copies/500 ng DNA Standard Deviation 27.62	0.61 Copies/500 ng DNA Standard Deviation 1.46
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load CMV: Baseline (n= 20, 19, 19)	0.00 Copies/500 ng DNA Standard Deviation 0.00	0.00 Copies/500 ng DNA Standard Deviation 0.00	0.00 Copies/500 ng DNA Standard Deviation 0.00
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load CMV: Month 1 (n= 20, 18, 18)	0.15 Copies/500 ng DNA Standard Deviation 0.49	43.50 Copies/500 ng DNA Standard Deviation 184.55	0.00 Copies/500 ng DNA Standard Deviation 0.00
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load CMV: Month 6 (n= 15, 13, 18)	58.87 Copies/500 ng DNA Standard Deviation 226.33	2.38 Copies/500 ng DNA Standard Deviation 5.45	0.00 Copies/500 ng DNA Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load Baseline (n= 20, 19, 19)	0.00 Copies/20 mcL plasma Standard Deviation 0.00	0.05 Copies/20 mcL plasma Standard Deviation 0.23	0.05 Copies/20 mcL plasma Standard Deviation 0.23
BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load Month 1 (n= 20, 18, 18)	0.00 Copies/20 mcL plasma Standard Deviation 0.00	5.33 Copies/20 mcL plasma Standard Deviation 22.13	0.00 Copies/20 mcL plasma Standard Deviation 0.00
BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load Month 3 (n= 18, 18, 20)	0.00 Copies/20 mcL plasma Standard Deviation 0.00	7.56 Copies/20 mcL plasma Standard Deviation 21.55	7.95 Copies/20 mcL plasma Standard Deviation 28.96
BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load Month 6 (n= 15, 13, 18)	5.07 Copies/20 mcL plasma Standard Deviation 16.55	189.85 Copies/20 mcL plasma Standard Deviation 664.27	0.06 Copies/20 mcL plasma Standard Deviation 0.24

SECONDARY outcome

Timeframe: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication and based on time due to lost of follow-up, or up to Month 6. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Cytomegalovirus (CMV) Disease Month 3 (n= 20, 19, 20)	0 participants	4 participants	0 participants
Number of Participants With Cytomegalovirus (CMV) Disease Month 6 (n= 19, 16, 20)	2 participants	4 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Monocyte: Day 14 (n= 18, 19, 18)	0.36 cells*10^3/mm^3 Standard Deviation 0.16	0.41 cells*10^3/mm^3 Standard Deviation 0.19	0.34 cells*10^3/mm^3 Standard Deviation 0.14
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Neutrophil: Month 3 (n= 19, 17, 20)	3.68 cells*10^3/mm^3 Standard Deviation 2.21	3.96 cells*10^3/mm^3 Standard Deviation 2.01	3.72 cells*10^3/mm^3 Standard Deviation 1.90
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil WBC: Baseline (n= 20, 20, 21)	12.75 cells*10^3/mm^3 Standard Deviation 3.79	11.09 cells*10^3/mm^3 Standard Deviation 3.57	11.82 cells*10^3/mm^3 Standard Deviation 5.16
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil WBC: Day 14 (n= 18, 19, 18)	12.76 cells*10^3/mm^3 Standard Deviation 3.68	13.81 cells*10^3/mm^3 Standard Deviation 3.49	10.24 cells*10^3/mm^3 Standard Deviation 3.10
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil WBC: Month 1 (n= 19,18, 19)	7.33 cells*10^3/mm^3 Standard Deviation 1.85	7.41 cells*10^3/mm^3 Standard Deviation 2.80	7.43 cells*10^3/mm^3 Standard Deviation 2.08
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil WBC: Month 3 (n= 19, 17, 20)	5.47 cells*10^3/mm^3 Standard Deviation 2.52	6.15 cells*10^3/mm^3 Standard Deviation 2.82	5.48 cells*10^3/mm^3 Standard Deviation 1.85
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil WBC: Month 6 (n= 16, 14, 18)	5.57 cells*10^3/mm^3 Standard Deviation 1.95	5.11 cells*10^3/mm^3 Standard Deviation 2.22	6.06 cells*10^3/mm^3 Standard Deviation 2.89
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Basophil: Baseline (n= 20, 20, 21)	0.04 cells*10^3/mm^3 Standard Deviation 0.05	0.01 cells*10^3/mm^3 Standard Deviation 0.03	0.02 cells*10^3/mm^3 Standard Deviation 0.04
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Basophil: Day 14 (n= 18, 19, 18)	0.09 cells*10^3/mm^3 Standard Deviation 0.07	0.11 cells*10^3/mm^3 Standard Deviation 0.08	0.05 cells*10^3/mm^3 Standard Deviation 0.05
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Basophil: Month 1 (n= 19,18, 19)	0.05 cells*10^3/mm^3 Standard Deviation 0.08	0.07 cells*10^3/mm^3 Standard Deviation 0.06	0.06 cells*10^3/mm^3 Standard Deviation 0.05
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Basophil: Month 3 (n= 19, 17, 20)	0.04 cells*10^3/mm^3 Standard Deviation 0.05	0.05 cells*10^3/mm^3 Standard Deviation 0.05	0.04 cells*10^3/mm^3 Standard Deviation 0.05
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Basophil: Month 6 (n= 16, 14, 18)	0.04 cells*10^3/mm^3 Standard Deviation 0.05	0.04 cells*10^3/mm^3 Standard Deviation 0.05	0.06 cells*10^3/mm^3 Standard Deviation 0.06
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Eosinophil: Baseline (n= 20, 20, 21)	0.08 cells*10^3/mm^3 Standard Deviation 0.08	0.06 cells*10^3/mm^3 Standard Deviation 0.08	0.12 cells*10^3/mm^3 Standard Deviation 0.20
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Eosinophil: Day 14 (n= 18, 19, 18)	0.17 cells*10^3/mm^3 Standard Deviation 0.13	0.21 cells*10^3/mm^3 Standard Deviation 0.12	0.13 cells*10^3/mm^3 Standard Deviation 0.08
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Eosinophil: Month 1 (n= 19,18, 19)	0.14 cells*10^3/mm^3 Standard Deviation 0.10	0.19 cells*10^3/mm^3 Standard Deviation 0.16	0.13 cells*10^3/mm^3 Standard Deviation 0.09
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Eosinophil: Month 3 (n= 19, 17, 20)	0.10 cells*10^3/mm^3 Standard Deviation 0.03	0.11 cells*10^3/mm^3 Standard Deviation 0.07	0.11 cells*10^3/mm^3 Standard Deviation 0.07
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Eosinophil: Month 6 (n= 16, 14, 18)	0.11 cells*10^3/mm^3 Standard Deviation 0.05	0.11 cells*10^3/mm^3 Standard Deviation 0.08	0.17 cells*10^3/mm^3 Standard Deviation 0.12
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Lymphocyte: Baseline (n= 20, 20, 21)	0.61 cells*10^3/mm^3 Standard Deviation 0.41	0.52 cells*10^3/mm^3 Standard Deviation 0.23	0.75 cells*10^3/mm^3 Standard Deviation 0.45
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Lymphocyte: Day 14 (n= 18, 19, 18)	2.03 cells*10^3/mm^3 Standard Deviation 1.43	2.48 cells*10^3/mm^3 Standard Deviation 1.40	1.84 cells*10^3/mm^3 Standard Deviation 0.93
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Lymphocyte: Month 1 (n= 19,18, 19)	1.96 cells*10^3/mm^3 Standard Deviation 1.22	1.77 cells*10^3/mm^3 Standard Deviation 0.79	1.81 cells*10^3/mm^3 Standard Deviation 0.76
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Lymphocyte: Month 3 (n= 19, 17, 20)	1.26 cells*10^3/mm^3 Standard Deviation 0.57	1.61 cells*10^3/mm^3 Standard Deviation 0.97	1.29 cells*10^3/mm^3 Standard Deviation 0.56
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Lymphocyte: Month 6 (n= 16, 14, 18)	1.44 cells*10^3/mm^3 Standard Deviation 0.61	1.28 cells*10^3/mm^3 Standard Deviation 0.81	1.47 cells*10^3/mm^3 Standard Deviation 0.68
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Monocyte: Baseline (n= 20, 20, 21)	0.58 cells*10^3/mm^3 Standard Deviation 0.44	0.39 cells*10^3/mm^3 Standard Deviation 0.22	0.44 cells*10^3/mm^3 Standard Deviation 0.26
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Monocyte: Month 1 (n= 19,18, 19)	0.26 cells*10^3/mm^3 Standard Deviation 0.12	0.32 cells*10^3/mm^3 Standard Deviation 0.13	0.28 cells*10^3/mm^3 Standard Deviation 0.09
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Monocyte: Month 3 (n= 19, 17, 20)	0.31 cells*10^3/mm^3 Standard Deviation 0.17	0.34 cells*10^3/mm^3 Standard Deviation 0.19	0.28 cells*10^3/mm^3 Standard Deviation 0.09
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Monocyte: Month 6 (n= 16, 14, 18)	0.31 cells*10^3/mm^3 Standard Deviation 0.15	0.25 cells*10^3/mm^3 Standard Deviation 0.15	0.34 cells*10^3/mm^3 Standard Deviation 0.12
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Neutrophil: Baseline (n= 20, 20, 21)	11.63 cells*10^3/mm^3 Standard Deviation 3.73	10.06 cells*10^3/mm^3 Standard Deviation 3.53	10.37 cells*10^3/mm^3 Standard Deviation 4.84
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Neutrophil: Day 14 (n= 18, 19, 18)	10.01 cells*10^3/mm^3 Standard Deviation 3.14	10.48 cells*10^3/mm^3 Standard Deviation 3.05	7.78 cells*10^3/mm^3 Standard Deviation 2.99
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Neutrophil: Month 1 (n= 19,18, 19)	4.85 cells*10^3/mm^3 Standard Deviation 1.86	4.93 cells*10^3/mm^3 Standard Deviation 2.50	5.05 cells*10^3/mm^3 Standard Deviation 1.82
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil Neutrophil: Month 6 (n= 16, 14, 18)	3.68 cells*10^3/mm^3 Standard Deviation 1.67	3.37 cells*10^3/mm^3 Standard Deviation 1.65	3.94 cells*10^3/mm^3 Standard Deviation 2.27

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Absolute Platelet Levels Platelet: Month 3 (n= 19, 17, 20)	273.84 platelets*10^3/mm^3 Standard Deviation 89.95	307.00 platelets*10^3/mm^3 Standard Deviation 92.40	241.60 platelets*10^3/mm^3 Standard Deviation 66.80
Absolute Platelet Levels Platelet: Month 6 (n= 16, 14, 18)	272.19 platelets*10^3/mm^3 Standard Deviation 88.19	263.43 platelets*10^3/mm^3 Standard Deviation 109.78	225.17 platelets*10^3/mm^3 Standard Deviation 59.53
Absolute Platelet Levels Platelet: Baseline (n= 20, 20, 21)	186.75 platelets*10^3/mm^3 Standard Deviation 59.33	204.85 platelets*10^3/mm^3 Standard Deviation 54.44	195.19 platelets*10^3/mm^3 Standard Deviation 47.97
Absolute Platelet Levels Platelet: Day 14 (n= 18, 19, 18)	330.17 platelets*10^3/mm^3 Standard Deviation 107.04	367.84 platelets*10^3/mm^3 Standard Deviation 101.31	301.28 platelets*10^3/mm^3 Standard Deviation 90.95
Absolute Platelet Levels Platelet: Month 1 (n= 19,18, 19)	249.68 platelets*10^3/mm^3 Standard Deviation 73.70	274.50 platelets*10^3/mm^3 Standard Deviation 88.30	276.79 platelets*10^3/mm^3 Standard Deviation 72.08

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Hemoglobin Level Baseline (n= 20, 20, 21)	11.04 g/dL Standard Deviation 1.48	10.65 g/dL Standard Deviation 1.43	11.84 g/dL Standard Deviation 1.37
Hemoglobin Level Day 14 (n= 19, 19, 18)	11.83 g/dL Standard Deviation 1.29	11.68 g/dL Standard Deviation 0.89	11.93 g/dL Standard Deviation 1.67
Hemoglobin Level Month 1 (n= 19, 18, 19)	12.16 g/dL Standard Deviation 1.04	12.29 g/dL Standard Deviation 1.12	12.20 g/dL Standard Deviation 1.42
Hemoglobin Level Month 3 (n= 19, 17, 20)	12.35 g/dL Standard Deviation 1.79	12.20 g/dL Standard Deviation 1.55	12.91 g/dL Standard Deviation 1.43
Hemoglobin Level Month 6 (n= 16, 14, 18)	12.83 g/dL Standard Deviation 1.54	12.41 g/dL Standard Deviation 1.99	14.26 g/dL Standard Deviation 1.32

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Hematocrit Level Baseline (n= 20, 20, 21)	34.75 percentage of blood Standard Deviation 4.82	33.30 percentage of blood Standard Deviation 5.02	36.86 percentage of blood Standard Deviation 5.18
Hematocrit Level Day 14 (n= 18, 19, 18)	37.78 percentage of blood Standard Deviation 3.73	37.16 percentage of blood Standard Deviation 3.50	37.11 percentage of blood Standard Deviation 4.83
Hematocrit Level Month 1 (n= 19, 18, 19)	38.74 percentage of blood Standard Deviation 2.81	38.22 percentage of blood Standard Deviation 3.89	37.95 percentage of blood Standard Deviation 3.99
Hematocrit Level Month 3 (n= 19, 17, 20)	38.53 percentage of blood Standard Deviation 5.30	37.12 percentage of blood Standard Deviation 4.37	39.50 percentage of blood Standard Deviation 4.05
Hematocrit Level Month 6 (n= 16, 14, 18)	40.19 percentage of blood Standard Deviation 3.75	37.86 percentage of blood Standard Deviation 6.14	43.67 percentage of blood Standard Deviation 3.88

SECONDARY outcome

Timeframe: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants evaluable at specific time points for each arm group respectively.

ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Alanine Aminotransferase (ALT) Level Baseline (n= 19, 20, 21)	24.84 unit/liter Standard Deviation 18.52	18.45 unit/liter Standard Deviation 9.39	18.33 unit/liter Standard Deviation 10.36
Alanine Aminotransferase (ALT) Level Month 3 (n= 18, 18, 20)	26.28 unit/liter Standard Deviation 10.56	36.22 unit/liter Standard Deviation 31.40	16.10 unit/liter Standard Deviation 6.98
Alanine Aminotransferase (ALT) Level Month 6 (n= 17, 14, 18)	31.06 unit/liter Standard Deviation 20.31	37.86 unit/liter Standard Deviation 19.81	23.28 unit/liter Standard Deviation 21.50
Alanine Aminotransferase (ALT) Level Day 14 (n= 19, 19, 20)	39.05 unit/liter Standard Deviation 35.77	70.63 unit/liter Standard Deviation 66.72	31.50 unit/liter Standard Deviation 27.89
Alanine Aminotransferase (ALT) Level Month 1 (n= 20, 18, 19)	28.95 unit/liter Standard Deviation 14.16	56.39 unit/liter Standard Deviation 57.47	21.32 unit/liter Standard Deviation 10.72

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=19 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=16 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=19 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Electrocardiogram (ECG) Parameters PR: Month 3 (n= 19, 15, 18)	156.37 millisecond Standard Deviation 20.22	156.00 millisecond Standard Deviation 59.08	150.17 millisecond Standard Deviation 20.38
Electrocardiogram (ECG) Parameters QT: Month 6 (n= 16, 13, 19)	401.44 millisecond Standard Deviation 28.53	383.85 millisecond Standard Deviation 33.68	384.68 millisecond Standard Deviation 20.24
Electrocardiogram (ECG) Parameters QTcB: Month 3 (n= 19, 16, 18)	417.25 millisecond Standard Deviation 27.22	412.23 millisecond Standard Deviation 29.22	409.81 millisecond Standard Deviation 34.15
Electrocardiogram (ECG) Parameters QTcF: Baseline (n= 15, 12, 17)	439.77 millisecond Standard Deviation 25.54	432.22 millisecond Standard Deviation 34.93	428.57 millisecond Standard Deviation 23.95
Electrocardiogram (ECG) Parameters QTcF: Month 3 (n= 19, 16, 18)	405.05 millisecond Standard Deviation 23.63	400.60 millisecond Standard Deviation 25.74	400.62 millisecond Standard Deviation 28.63
Electrocardiogram (ECG) Parameters QRS: Baseline (n= 15, 12, 17)	88.80 millisecond Standard Deviation 12.21	102.67 millisecond Standard Deviation 29.47	92.82 millisecond Standard Deviation 9.08
Electrocardiogram (ECG) Parameters QRS: Month 6 (n= 16, 13, 19)	91.75 millisecond Standard Deviation 16.13	90.31 millisecond Standard Deviation 32.15	89.74 millisecond Standard Deviation 9.89
Electrocardiogram (ECG) Parameters QTcB: Baseline (n= 15, 12, 17)	454.77 millisecond Standard Deviation 27.29	447.37 millisecond Standard Deviation 36.95	447.42 millisecond Standard Deviation 22.44
Electrocardiogram (ECG) Parameters QTcB: Month 6 (n= 16, 13, 19)	416.83 millisecond Standard Deviation 21.01	410.48 millisecond Standard Deviation 22.24	413.55 millisecond Standard Deviation 25.05
Electrocardiogram (ECG) Parameters QTcF: Month 6 (n= 16, 13, 19)	411.44 millisecond Standard Deviation 20.17	401.24 millisecond Standard Deviation 24.06	403.41 millisecond Standard Deviation 17.51
Electrocardiogram (ECG) Parameters QRS: Month 3 (n= 19, 16, 18)	87.74 millisecond Standard Deviation 14.18	102.13 millisecond Standard Deviation 39.78	88.22 millisecond Standard Deviation 10.14
Electrocardiogram (ECG) Parameters PR: Baseline (n= 15, 11, 17)	147.60 millisecond Standard Deviation 21.18	141.82 millisecond Standard Deviation 50.77	151.53 millisecond Standard Deviation 16.92
Electrocardiogram (ECG) Parameters PR: Month 6 (n= 16, 13, 19)	161.44 millisecond Standard Deviation 24.43	163.23 millisecond Standard Deviation 26.94	154.53 millisecond Standard Deviation 23.21
Electrocardiogram (ECG) Parameters QT: Baseline (n= 15, 12, 17)	412.40 millisecond Standard Deviation 38.35	404.50 millisecond Standard Deviation 43.33	393.88 millisecond Standard Deviation 34.75
Electrocardiogram (ECG) Parameters QT: Month 3 (n= 19, 16, 18)	383.32 millisecond Standard Deviation 38.00	378.88 millisecond Standard Deviation 28.47	384.00 millisecond Standard Deviation 33.23

SECONDARY outcome

Timeframe: Month 1, 2, 3, 4, 5, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	CP-690,550 15 mg n=20 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=20 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=21 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Number of Participants With Discontinuation Month 2	1 participants	1 participants	0 participants
Number of Participants With Discontinuation Month 4	1 participants	2 participants	1 participants
Number of Participants With Discontinuation Month 5	2 participants	4 participants	1 participants
Number of Participants With Discontinuation Month 6	2 participants	6 participants	1 participants
Number of Participants With Discontinuation Month 1	0 participants	1 participants	0 participants
Number of Participants With Discontinuation Month 3	1 participants	1 participants	1 participants

Adverse Events

CP-690,550 15 mg

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

CP-690,550 30 mg

Serious events: 10 serious events

Other events: 18 other events

Deaths: 0 deaths

Tacrolimus

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	CP-690,550 15 mg n=19 Participants CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	CP-690,550 30 mg n=19 Participants CP-690,550 30 mg tablet orally twice daily up to Month 6.	Tacrolimus n=20 Participants Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD8: Day 14 (n= 19, 19, 19)	449.84 cells per microliter (cells/mcL) Standard Deviation 327.09	471.79 cells per microliter (cells/mcL) Standard Deviation 335.83	401.68 cells per microliter (cells/mcL) Standard Deviation 313.64
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD8: Month 3 (n= 18, 18, 20)	212.94 cells per microliter (cells/mcL) Standard Deviation 133.54	252.72 cells per microliter (cells/mcL) Standard Deviation 165.94	261.35 cells per microliter (cells/mcL) Standard Deviation 156.93
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD8: Month 6 (n= 14, 11, 15)	278.93 cells per microliter (cells/mcL) Standard Deviation 198.35	201.09 cells per microliter (cells/mcL) Standard Deviation 180.41	300.33 cells per microliter (cells/mcL) Standard Deviation 195.51
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD19: Baseline (n= 19, 19, 19)	69.74 cells per microliter (cells/mcL) Standard Deviation 47.60	89.37 cells per microliter (cells/mcL) Standard Deviation 74.13	111.32 cells per microliter (cells/mcL) Standard Deviation 90.13
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD56: Day 14 (n= 19, 19, 19)	163.11 cells per microliter (cells/mcL) Standard Deviation 162.67	151.68 cells per microliter (cells/mcL) Standard Deviation 113.41	212.00 cells per microliter (cells/mcL) Standard Deviation 294.38
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD8: Baseline (n= 19, 19, 19)	113.95 cells per microliter (cells/mcL) Standard Deviation 80.91	114.05 cells per microliter (cells/mcL) Standard Deviation 86.28	160.37 cells per microliter (cells/mcL) Standard Deviation 146.56
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD8: Month 1 (n= 17, 18, 19)	333.00 cells per microliter (cells/mcL) Standard Deviation 226.24	354.39 cells per microliter (cells/mcL) Standard Deviation 245.74	380.89 cells per microliter (cells/mcL) Standard Deviation 257.68
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD19: Day 14 (n= 19, 19, 19)	353.68 cells per microliter (cells/mcL) Standard Deviation 418.37	486.84 cells per microliter (cells/mcL) Standard Deviation 410.32	303.95 cells per microliter (cells/mcL) Standard Deviation 302.66
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD19: Month 1 (n= 17, 18, 19)	282.41 cells per microliter (cells/mcL) Standard Deviation 334.27	291.28 cells per microliter (cells/mcL) Standard Deviation 208.87	343.58 cells per microliter (cells/mcL) Standard Deviation 301.42
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD19: Month 3 (n= 18, 18, 20)	128.39 cells per microliter (cells/mcL) Standard Deviation 87.89	217.67 cells per microliter (cells/mcL) Standard Deviation 276.83	168.20 cells per microliter (cells/mcL) Standard Deviation 138.10
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD19: Month 6 (n= 14, 11, 15)	156.50 cells per microliter (cells/mcL) Standard Deviation 75.62	176.18 cells per microliter (cells/mcL) Standard Deviation 169.09	188.80 cells per microliter (cells/mcL) Standard Deviation 130.84
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD56: Baseline (n= 19, 19, 19)	153.89 cells per microliter (cells/mcL) Standard Deviation 120.10	127.84 cells per microliter (cells/mcL) Standard Deviation 54.51	165.95 cells per microliter (cells/mcL) Standard Deviation 97.05
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD56: Month 1 (n= 17, 18, 19)	214.29 cells per microliter (cells/mcL) Standard Deviation 399.94	101.11 cells per microliter (cells/mcL) Standard Deviation 91.63	162.16 cells per microliter (cells/mcL) Standard Deviation 80.31
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD56: Month 3 (n= 18, 18, 20)	85.56 cells per microliter (cells/mcL) Standard Deviation 69.64	70.00 cells per microliter (cells/mcL) Standard Deviation 49.56	144.15 cells per microliter (cells/mcL) Standard Deviation 80.96
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets CD56: Month 6 (n= 14, 11, 15)	126.71 cells per microliter (cells/mcL) Standard Deviation 153.23	36.27 cells per microliter (cells/mcL) Standard Deviation 47.13	173.53 cells per microliter (cells/mcL) Standard Deviation 119.79