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

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

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

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

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).

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).

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

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.

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

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.

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.

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).

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).

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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

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.

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

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

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.