Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

A Multicenter, Phase 2, Open-label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 Versus Tacrolimus, When Co-administered With Mycophenolate Mofetil In Renal Allograft Recipients

A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Tacrolimus; Drug: CP-690,550; Drug: CP-690,550

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • St. Vincent Medical Center
    • Los Angeles, California, United States, 90057
      • Transplant Research Institute
    • Los Angeles, California, United States, 90057
      • Multi Organ Transplant Center
    • Palo Alto, California, United States, 94304
      • Stanford School of Medicine
    • San Diego, California, United States, 92123
      • California Institute of Renal Research
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Diego, California, United States, 92123
      • Balboa Institute of Transplantation
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco, Kidney Transplant Unit
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center Renal Clinical Trials Office
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern University-Feinberg School of Medicine, Division of Organ Transplantation
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10029
      • Recanati/Miller Transplantation Institute
    • New York, New York, United States, 10021
      • Jack J Dreyfus Clinic
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital / Weill Cornell Medical Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Hospital
    • Portland, Oregon, United States, 97210
      • Legacy Transplant Services
    • Portland, Oregon, United States, 97210
      • Northwest Renal Clinic
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75246
      • Annette C & Harold C Simmons Transplant Institute
    • Dallas, Texas, United States, 75204
      • Dallas Transplant Institute
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
• Recipient of a first-time kidney transplant

Exclusion Criteria:

• Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
• Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group 1; Standard of care	Drug: Tacrolimus; Standard of care
Experimental: Treatment group 2; Treatment group 2 also receives mycophenolate mofetil	Drug: CP-690,550; CP-690,550 5 mg BID; Drug: CP-690,550; CP-690,550 10 mg BID
Experimental: Treatment group 3; Treatment group 3 does not receive mycophenolate mofetil	Drug: CP-690,550; CP-690,550 5 mg BID; Drug: CP-690,550; CP-690,550 10 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation	GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine [in milligrams per deciliter (mg/dL)])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen [BUN] concentration [mg/dL])^(-0.170) * (serum albumin concentration [in grams per dL (g/dL)])^(0.318). A normal GFR is >90 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Serum Creatinine Levels		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit	Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit	Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (≥)30 days.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Percentage of Participants With Hypercholesterolemia	Hypercholesterolemia was defined as cholesterol levels >240 mg/dL or 6.2 mmol/L.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)
Percentage of Participants With Hypertriglyceridemia by Visit	Hypertriglyceridemia was defined as triglyceride levels of >200 mg/dL or 2.3 mmol/L.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit	Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit	Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated GFR Using the Nankivell Equation (mL/Min)	GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine [in millimoles per liter (mmol/L)]) plus (0.25*body weight [in kilograms (kg)]) minus (0.5*serum urea [mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea]) minus (100 per height [in meters] square) plus (35 for male/25 for female). 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.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)	GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). 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.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Reciprocal of Serum Creatinine		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit	Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels ≥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose ≥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose ≥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Total Cholesterol Levels by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Low-Density Lipoprotein (LDL) Levels by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
High-Density Lipoprotein (HDL) Levels by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Ratio of Total Serum Cholesterol Level to HDL Level by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Ratio of Serum LDL Level to HDL Level by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Serum Triglyceride Levels by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Percentage of Participants Requiring Lipid-Lowering Agents by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit	Calculated as number of copies per 500 mg DNA.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit	EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and >1000 copies/PCR.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)
BK Virus (BKV) DNA Levels Determined Using PCR by Visit	Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit	Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.	Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit	Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit	Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR	Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.	Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN	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).	Months 12, 18, 24, 36, 48, 60, 72, 84, and 96
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit	Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit	Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for ≥6 consecutive weeks, or death.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit	Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit	Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.	Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit		Months 12 and 24
Hemoglobin A1c (HbA1c) Levels by Visit		Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)
Homeostatic Model Assessment (HOMA)-%B by Visit	HOMA-%B = (20 times [*] fasting serum insulin) divided by (/) (fasting serum glucose minus [-] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.	Months 12 and 24
Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit	Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.	Months 12 and 24
Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit	Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.	Months 12 and 24
AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit	The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.	Months 12 and 24
HOMA Insulin Resistance (IR) by Visit	HOMA-IR=fasting serum insulin*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.	Months 12 and 24
Fasting Serum Glucose Levels (mg/dL) by Visit		Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Tofacitinib Concentrations in Plasma (ng/mL) by Visit		Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)
Trough Levels of Tacrolimus (ng/mL) by Visit		Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale	The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (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 (PCS and MCS). 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).	Months 12, 18, and 24
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale	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 PCS and MCS. 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). Negative change from baseline represented improvement.	Baseline, Months 12, 18, and 24
SF-36 v2 Subscale Scores by Visit	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 PCS and MCS. 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).	Months 12, 18, and 24
Change From Baseline in SF-36 v2 Subscale Scores by Visit	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 PCS and MCS. 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). Negative change from baseline represented improvement.	Baseline, Months 12, 18, and 24
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale	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 from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.	Months 12, 18, and 24
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale	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 from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.	Baseline, Months 12, 18, and 24
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire	HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 12, 18, and 24

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 6, 2005
• First Submitted That Met QC Criteria: December 6, 2005
• First Posted (Estimate): December 8, 2005

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: immunosuppression; tofacitinib; kidney transplant; Xeljanz; mycophenolate mofetil; CP-690; 550; JAK3 inhibitor; tacromilus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Calcineurin Inhibitors; Tacrolimus; Tofacitinib
• Other Study ID Numbers: A3921021