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This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CP-690,550 5 mg BID | Experimental |
| |
| CP-690,550 15 mg BID | Experimental |
| |
| CP-690,550 30 mg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tables twice daily (BID) for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
| Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550 | Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state. | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29 |
| Maximum Observed Plasma Concentration (Cmax) For CP-690,550 | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 | |
| Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550 | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550 | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550 | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
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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 | Birmingham | Alabama | 35249-6860 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Stage 1 | Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1. |
| FG001 | CP-690,550 5 mg, Stage 1 | CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1. |
| FG002 | CP-690,550 15 mg, Stage 1 | CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1. |
| FG003 | CP-690,550 30 mg, Stage 1 | CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1. |
| FG004 | CP-690,550 30 mg, Stage 2 | CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
| |||||||||||||
| Stage 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Stage 1 | Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo, Stage 1 | Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
| C494814 | BID protein, human |
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| CP-690,550 5 mg BID |
| Drug |
CP-690,550 5 mg BID for 28 days |
|
| CP-690,550 15 mg BID | Drug | CP-690,550 15 mg BID for 28 days |
|
| CP-690,550 30 mg BID | Drug | CP-690,550 30 mg BID for 28 days |
|
| Accumulation Ratio (Rac) For CP-690,550 | Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1). | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29 |
| Plasma Decay Half-Life (t1/2) For CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 |
| Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state. | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
| Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline | Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | Screening, 0 hour (pre-dose) on Day 1 |
| Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 8 |
| Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 15 |
| Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 29 |
| Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 57 |
| Cyclosporine (CsA) Plasma Trough Concentration at Baseline | The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | Screening, 0 hour (pre-dose) on Day 1 |
| Cyclosporine (CsA) Plasma Trough Concentration at Day 8 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 8 |
| Cyclosporine (CsA) Plasma Trough Concentration at Day 15 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 15 |
| Cyclosporine (CsA) Plasma Trough Concentration at Day 29 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 29 |
| Cyclosporine (CsA) Plasma Trough Concentration at Day 57 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 57 |
| Tacrolimus (TAC) Plasma Trough Concentration at Baseline | The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | Screening, 0 hour (pre-dose) on Day 1 |
| Tacrolimus (TAC) Plasma Trough Concentration at Day 8 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 8 |
| Tacrolimus (TAC) Plasma Trough Concentration at Day 15 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 15 |
| Tacrolimus (TAC) Plasma Trough Concentration at Day 29 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 29 |
| Tacrolimus (TAC) Plasma Trough Concentration at Day 57 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | 0 hour (pre-dose) on Day 57 |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35294-6862 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90057 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110-1092 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110-1093 | United States |
| Pfizer Investigational Site | Livingston | New Jersey | 07039 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792 | United States |
| Pfizer Investigational Site |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| CP-690,550 5 mg, Stage 1 |
CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1. |
| BG002 | CP-690,550 15 mg, Stage 1 | CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1. |
| BG003 | CP-690,550 30 mg, Stage 1 And 2 | CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | CP-690,550 15 mg, Stage 1 | CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1. |
| OG002 | CP-690,550 30 mg, Stage 1 And 2 | CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2. |
|
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
|
|
|
| Primary | Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550 | Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29 |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) For CP-690,550 | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550 | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550 | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Median | Full Range | hours | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550 | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Median | Full Range | hours | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
|
|
|
| Primary | Accumulation Ratio (Rac) For CP-690,550 | Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1). | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ratio | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29 |
|
|
|
| Primary | Plasma Decay Half-Life (t1/2) For CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | hours | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 |
|
|
|
| Primary | Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | hours | 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 |
|
|
|
| Primary | Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline | Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | Milligram per Liter (mg/L) | Screening, 0 hour (pre-dose) on Day 1 |
|
|
|
| Primary | Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | mg/L | 0 hour (pre-dose) on Day 8 |
|
|
|
| Primary | Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | mg/L | 0 hour (pre-dose) on Day 15 |
|
|
|
| Primary | Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | mg/L | 0 hour (pre-dose) on Day 29 |
|
|
|
| Primary | Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57 | Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | mg/L | 0 hour (pre-dose) on Day 57 |
|
|
|
| Primary | Cyclosporine (CsA) Plasma Trough Concentration at Baseline | The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | Screening, 0 hour (pre-dose) on Day 1 |
|
|
|
| Primary | Cyclosporine (CsA) Plasma Trough Concentration at Day 8 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 8 |
|
|
|
| Primary | Cyclosporine (CsA) Plasma Trough Concentration at Day 15 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 15 |
|
|
|
| Primary | Cyclosporine (CsA) Plasma Trough Concentration at Day 29 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 29 |
|
|
|
| Primary | Cyclosporine (CsA) Plasma Trough Concentration at Day 57 | CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 57 |
|
|
|
| Primary | Tacrolimus (TAC) Plasma Trough Concentration at Baseline | The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | Screening, 0 hour (pre-dose) on Day 1 |
|
|
|
| Primary | Tacrolimus (TAC) Plasma Trough Concentration at Day 8 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 8 |
|
|
|
| Primary | Tacrolimus (TAC) Plasma Trough Concentration at Day 15 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 15 |
|
|
|
| Primary | Tacrolimus (TAC) Plasma Trough Concentration at Day 29 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 29 |
|
|
|
| Primary | Tacrolimus (TAC) Plasma Trough Concentration at Day 57 | TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. | Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 57 |
|
|
|
| 1 |
| 6 |
| 5 |
| 6 |
| EG001 | CP-690,550 5 mg, Stage 1 | CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1. | 0 | 6 | 5 | 6 |
| EG002 | CP-690,550 15 mg, Stage 1 | CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1. | 2 | 6 | 5 | 6 |
| EG003 | CP-690,550 30 mg, Stage 1 And 2 | CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2. | 1 | 10 | 8 | 10 |
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Gingival hyperplasia | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
| Reticulocyte count decreased | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.0 | Non-systematic Assessment |
|
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.