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This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-690,550 15 mg BID | Experimental |
| |
| CP-690,550 30 mg BID | Experimental |
| |
| tacrolimus | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | 15 mg twice daily |
| |
| CP-690,550 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6 | BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. | Baseline up to Month 6 |
| Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 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 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Failure | Treatment failure was defined as the first occurrence of BPAR, graft loss, participant's death or premature discontinuation of study medication for any reason. | Month 3, 6 |
| Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Los Angeles | California | 90057 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19660021 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CP-690,550 15 mg | CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6. |
| FG001 | CP-690,550 30 mg | CP-690,550 30 mg tablet orally twice daily up to Month 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
30 mg twice daily |
|
| tacrolimus | Drug | dose adjusted according to level |
|
BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. |
| Baseline up to Month 3 |
| Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) | BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification. | Month 3, 6 |
| Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) | 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). | Month 3, 6 |
| Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (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). | Month 3, 6 |
| Number of Participants With Efficacy Failure | Efficacy failure was the first occurrence of BPAR, graft loss or participant's death. | Month 3, 6 |
| Number of Participants With Graft Loss | 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. | Month 6 |
| Number of Participants Who Died | Month 6 |
| Number of Participants With Rejection | Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection. | Month 3, 6 |
| Population Pharmacokinetics (PK) | 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. | 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 |
| Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets | 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. | Baseline, Day 14, Month 1, 3, 6 |
| Reticulocyte Count | 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). | Baseline, Day 14, Month 1, 3, 6 |
| Trough Levels of Tacrolimus (TAC) | Pre-dose on Day 14, Month 1, 3, 6 |
| 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) | 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). | Baseline, Month 6 |
| End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) | 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. | Baseline, Month 6 |
| Healthcare Resource Utilization Questionnaire (HCRUQ) | 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. | Baseline, Month 6 |
| Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question | 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. | Month 6 |
| Glomerular Filtration Rate (GFR) by Cockcroft-Gault | 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. | Day 14, Month 1, 3, 6 |
| Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation | 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. | Day 14, Month 1, 3, 6 |
| Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) | GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR. | Day 14, Month 1, 3, 6 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Baseline up to Month 8 (2 months follow-up) |
| Number of Participants With First Clinically Significant Infection | 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. | Month 3, 6 |
| Number of Participants With New Onset Diabetes Mellitus (NODM) | Month 3, 6 |
| Fasting Serum Glucose Levels | Baseline, Day 14, Month 1, 3, 6 |
| Number of Participants With Hypercholesterolemia | 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. | Baseline, Day 14, Month 1, 3, 6 |
| Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels | Baseline, Day 14, Month 1, 3, 6 |
| Number of Participants With Hypertriglyceridemia | Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL. | Baseline, Day 14, Month 1, 3, 6 |
| Supine Systolic and Diastolic Blood Pressure (BP) | Baseline, Day 2, 3, 14, Month 1, 3, 6 |
| Number of Participants With Drug Usage | Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected. | Baseline, Day 14, Month 1, 3, 6 |
| Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load | Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV |
| BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load | Baseline, Month 1, 3, 6 |
| Number of Participants With Cytomegalovirus (CMV) Disease | Month 3, 6 |
| Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil | Baseline, Day 14, Month 1, 3, 6 |
| Absolute Platelet Levels | Baseline, Day 14, Month 1, 3, 6 |
| Hemoglobin Level | 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. | Baseline, Day 14, Month 1, 3, 6 |
| Hematocrit Level | The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample. | Baseline, Day 14, Month 1, 3, 6 |
| Alanine Aminotransferase (ALT) Level | ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased. | Baseline, Day 14, Month 1, 3, 6 |
| Electrocardiogram (ECG) Parameters | 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. | Baseline, Month 3, 6 |
| Number of Participants With Discontinuation | Month 1, 2, 3, 4, 5, 6 |
| Los Angeles |
| California |
| 92356 |
| United States |
| Pfizer Investigational Site | Palo Alto | California | 94304 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | San Francisco | California | 94143-0780 | United States |
| Pfizer Investigational Site | Stanford | California | 94305 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80262 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70112 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110-1092 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Livingston | New Jersey | 07039 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75204 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23298 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| FG002 | Tacrolimus | Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CP-690,550 15 mg | CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6. |
| BG001 | CP-690,550 30 mg | CP-690,550 30 mg tablet orally twice daily up to Month 6. |
| BG002 | Tacrolimus | Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6 | BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Month 6 |
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| Primary | Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 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 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. | 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. | Posted | Mean | Standard Deviation | mL/min | Month 6 |
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| Secondary | Number of Participants With Treatment Failure | Treatment failure was defined as the first occurrence of BPAR, graft loss, participant's death or premature discontinuation of study medication for any reason. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
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| Secondary | Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3 | BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Month 3 |
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| Secondary | Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) | BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
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| Secondary | Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) | 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). | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
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| Secondary | Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (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). | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
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| Secondary | Number of Participants With Efficacy Failure | Efficacy failure was the first occurrence of BPAR, graft loss or participant's death. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
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| Secondary | Number of Participants With Graft Loss | 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. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 6 |
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| Secondary | Number of Participants Who Died | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 6 |
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| Secondary | Number of Participants With Rejection | Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
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| Secondary | Population Pharmacokinetics (PK) | 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. | Not Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 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 | |||||||||||||||||||||||||||||||||||
| Secondary | Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets | 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. | 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. | Posted | Mean | Standard Deviation | cells per microliter (cells/mcL) | Baseline, Day 14, Month 1, 3, 6 |
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| Secondary | Reticulocyte Count | 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). | 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. | Posted | Mean | Standard Deviation | cells*10^3/mm^3 | Baseline, Day 14, Month 1, 3, 6 |
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| Secondary | Trough Levels of Tacrolimus (TAC) | 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. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Pre-dose on Day 14, Month 1, 3, 6 |
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| Secondary | 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
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| Secondary | Healthcare Resource Utilization Questionnaire (HCRUQ) | 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. | 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. | Posted | Mean | Standard Deviation | events | Baseline, Month 6 |
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| Secondary | Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question | 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. | 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. | Posted | Number | participants | Month 6 |
|
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| Secondary | Glomerular Filtration Rate (GFR) by Cockcroft-Gault | 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. | 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. | Posted | Mean | Standard Deviation | mL/min | Day 14, Month 1, 3, 6 |
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| Secondary | Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation | 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. | 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 group respectively. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Day 14, Month 1, 3, 6 |
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| Secondary | Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) | GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR. | 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. | Posted | Mean | Standard Deviation | deciliter/mg (dL/mg) | Day 14, Month 1, 3, 6 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Month 8 (2 months follow-up) |
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| Secondary | Number of Participants With First Clinically Significant Infection | 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. | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New Onset Diabetes Mellitus (NODM) | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 3, 6 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Fasting Serum Glucose Levels | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hypercholesterolemia | 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. | 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. | Posted | Number | participants | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hypertriglyceridemia | Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL. | 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 group respectively. | Posted | Number | participants | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Supine Systolic and Diastolic Blood Pressure (BP) | 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. | Posted | Mean | Standard Deviation | millimeter of mercury | Baseline, Day 2, 3, 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Drug Usage | Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected. | 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. | Posted | Number | participants | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load | 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. | Posted | Mean | Standard Deviation | Copies/500 ng DNA | Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV |
|
| |||||||||||||||||||||||||||||||||
| Secondary | BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load | 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. | Posted | Mean | Standard Deviation | Copies/20 mcL plasma | Baseline, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cytomegalovirus (CMV) Disease | 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. | Posted | Number | participants | Month 3, 6 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil | 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. | Posted | Mean | Standard Deviation | cells*10^3/mm^3 | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Absolute Platelet Levels | 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. | Posted | Mean | Standard Deviation | platelets*10^3/mm^3 | Baseline, Day 14, Month 1, 3, 6 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin Level | 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. | 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. | Posted | Mean | Standard Deviation | g/dL | Baseline, Day 14, Month 1, 3, 6 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Hematocrit Level | The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample. | 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. | Posted | Mean | Standard Deviation | percentage of blood | Baseline, Day 14, Month 1, 3, 6 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) Level | ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased. | 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. | Posted | Mean | Standard Deviation | unit/liter | Baseline, Day 14, Month 1, 3, 6 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Electrocardiogram (ECG) Parameters | 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. | 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. | Posted | Mean | Standard Deviation | millisecond | Baseline, Month 3, 6 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Discontinuation | FAS included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Month 1, 2, 3, 4, 5, 6 |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP-690,550 15 mg | CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6. | 8 | 20 | 20 | 20 | ||
| EG001 | CP-690,550 30 mg | CP-690,550 30 mg tablet orally twice daily up to Month 6. | 10 | 20 | 18 | 20 | ||
| EG002 | Tacrolimus | Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6. | 6 | 21 | 20 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Ureteric injury | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pitting oedema | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Human polyomavirus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Medical device pain | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Blood testosterone decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Immunosuppressant drug level increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Vascular resistance systemic increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Viral test positive | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Virus urine test positive | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Aura | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nephritis interstitial | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nasopharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Medical device implantation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
| |
| Wound drainage | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
Results for first BPAR, BPCAN, treatment and efficacy failure, rejection, clinically significant infections, NODM and discontinuation reported as number and not percentage as planned. Stage 2 of study was not conducted due to administrative reasons.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
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| Participants |
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Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
|
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Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
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| Units | Counts |
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| Participants |
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Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6. |
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| Participants |
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| Participants |
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