Trial Outcomes & Findings for A Study Of CP-690,550 In Stable Kidney Transplant Patients (NCT NCT01710033)

NCT ID: NCT01710033

Last Updated: 2012-12-26

Results Overview

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

Results posted on

2012-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Stage 1 STARTED	6	6	6	6	0
Stage 1 COMPLETED	6	6	6	6	0
Stage 1 NOT COMPLETED	0	0	0	0	0
Stage 2 STARTED	0	0	0	0	4
Stage 2 COMPLETED	0	0	0	0	3
Stage 2 NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Stage 2 Adverse Event	0	0	0	0	1

Baseline Characteristics

A Study Of CP-690,550 In Stable Kidney Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo, Stage 1 n=6 Participants 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.	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 Participants 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.	Total n=28 Participants Total of all reporting groups
Age Continuous	54.5 years STANDARD_DEVIATION 15.0 • n=5 Participants	53.0 years STANDARD_DEVIATION 15.5 • n=7 Participants	46.0 years STANDARD_DEVIATION 17.8 • n=5 Participants	54.2 years STANDARD_DEVIATION 14.3 • n=4 Participants	52.3 years STANDARD_DEVIATION 15.0 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	20 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

Population: 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.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=8 Participants 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.	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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550	183 nanogramhour per milliliter (nghr/mL) Standard Deviation 75.3	754 nanogramhour per milliliter (nghr/mL) Standard Deviation 182	1200 nanogramhour per milliliter (nghr/mL) Standard Deviation 266	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=9 Participants 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.	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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550	319 ng*hr/mL Standard Deviation 175	1300 ng*hr/mL Standard Deviation 241	1560 ng*hr/mL Standard Deviation 311	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29

Area under the plasma concentration time-curve from zero to 12 hour concentration \[AUC(0-12)\] at steady state.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=9 Participants 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.	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.
Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550	273 ng*hr/mL Standard Deviation 132	1090 ng*hr/mL Standard Deviation 150	1420 ng*hr/mL Standard Deviation 253	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=8 Participants 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.	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.
Maximum Observed Plasma Concentration (Cmax) For CP-690,550	41.0 nanogram per milliliter (ng/mL) Standard Deviation 14.9	140 nanogram per milliliter (ng/mL) Standard Deviation 34.5	325 nanogram per milliliter (ng/mL) Standard Deviation 113	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=9 Participants 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.	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.
Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550	52.2 ng/mL Standard Deviation 15.2	220 ng/mL Standard Deviation 39.4	351 ng/mL Standard Deviation 46.3	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=8 Participants 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.	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.
Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550	0.75 hours Interval 0.5 to 2.0	1.50 hours Interval 0.5 to 2.0	0.50 hours Interval 0.5 to 2.0	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=9 Participants 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.	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.
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550	0.75 hours Interval 0.5 to 2.0	0.50 hours Interval 0.5 to 1.0	0.50 hours Interval 0.5 to 1.0	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29

Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=7 Participants 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.	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.
Accumulation Ratio (Rac) For CP-690,550	1.48 ratio Standard Deviation 0.467	1.39 ratio Standard Deviation 0.245	1.22 ratio Standard Deviation 0.182	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=4 Participants 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.	CP-690,550 15 mg, Stage 1 n=2 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=8 Participants 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.	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.
Plasma Decay Half-Life (t1/2) For CP-690,550	3.36 hours Standard Deviation 0.869	NA hours Standard Deviation NA Data was not analyzed because there were not enough participants to perform a meaningful analysis.	2.94 hours Standard Deviation 0.620	—

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=4 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=8 Participants 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.	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.
Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550	5.18 hours Standard Deviation 2.00	5.15 hours Standard Deviation 1.12	3.71 hours Standard Deviation 0.201	—

PRIMARY outcome

Timeframe: Screening, 0 hour (pre-dose) on Day 1

Population: Analysis population included all randomized participants who received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 Participants 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.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline	2.73 Milligram per Liter (mg/L) Standard Deviation 1.23	2.18 Milligram per Liter (mg/L) Standard Deviation 1.80	1.84 Milligram per Liter (mg/L) Standard Deviation 1.13	2.43 Milligram per Liter (mg/L) Standard Deviation 1.80

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 8

Population: Analysis population included all randomized participants who received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 Participants 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.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8	3.25 mg/L Standard Deviation 2.77	2.11 mg/L Standard Deviation 2.01	1.29 mg/L Standard Deviation 0.48	2.56 mg/L Standard Deviation 1.62

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 15

Population: Analysis population included all randomized participants who received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 Participants 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.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15	3.15 mg/L Standard Deviation 1.75	2.36 mg/L Standard Deviation 2.21	1.48 mg/L Standard Deviation 0.63	2.74 mg/L Standard Deviation 1.52

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 29

Population: Analysis population included all randomized participants who received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 Participants 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.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29	2.61 mg/L Standard Deviation 1.77	2.68 mg/L Standard Deviation 2.00	4.30 mg/L Standard Deviation 3.88	3.24 mg/L Standard Deviation 1.71

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on 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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=6 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=6 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 Participants 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.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57	2.60 mg/L Standard Deviation 1.56	2.89 mg/L Standard Deviation 2.75	1.75 mg/L Standard Deviation 1.10	2.67 mg/L Standard Deviation 1.87

PRIMARY outcome

Timeframe: Screening, 0 hour (pre-dose) on Day 1

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=1 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=3 Participants 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.	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.
Cyclosporine (CsA) Plasma Trough Concentration at Baseline	249.50 ng/mL Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	81.00 ng/mL Standard Deviation 41.99	173.00 ng/mL Standard Deviation 51.11	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 8

CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=1 Participants 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.	CP-690,550 15 mg, Stage 1 n=4 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=3 Participants 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.	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.
Cyclosporine (CsA) Plasma Trough Concentration at Day 8	137.00 ng/mL Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	77.25 ng/mL Standard Deviation 47.28	134.00 ng/mL Standard Deviation 17.78	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 15

CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=1 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=3 Participants 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.	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.
Cyclosporine (CsA) Plasma Trough Concentration at Day 15	207.00 ng/mL Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	86.60 ng/mL Standard Deviation 43.71	160.33 ng/mL Standard Deviation 24.58	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 29

CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=1 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=3 Participants 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.	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.
Cyclosporine (CsA) Plasma Trough Concentration at Day 29	226.00 ng/mL Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	96.00 ng/mL Standard Deviation 53.43	125.00 ng/mL Standard Deviation 22.34	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 57

CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=1 Participants 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.	CP-690,550 15 mg, Stage 1 n=5 Participants 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.	CP-690,550 30 mg, Stage 1 And 2 n=3 Participants 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.	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.
Cyclosporine (CsA) Plasma Trough Concentration at Day 57	292.00 ng/mL Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.	91.20 ng/mL Standard Deviation 72.71	152.00 ng/mL Standard Deviation 43.28	—

PRIMARY outcome

Timeframe: Screening, 0 hour (pre-dose) on Day 1

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=2 Participants 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.	CP-690,550 15 mg, Stage 1 n=3 Participants 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.	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.	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.
Tacrolimus (TAC) Plasma Trough Concentration at Baseline	6.75 ng/mL Standard Deviation 2.47	7.17 ng/mL Standard Deviation 1.76	—	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 8

TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=2 Participants 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.	CP-690,550 15 mg, Stage 1 n=3 Participants 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.	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.	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.
Tacrolimus (TAC) Plasma Trough Concentration at Day 8	7.50 ng/mL Standard Deviation 2.12	8.00 ng/mL Standard Deviation 1.00	—	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 15

TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=2 Participants 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.	CP-690,550 15 mg, Stage 1 n=3 Participants 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.	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.	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.
Tacrolimus (TAC) Plasma Trough Concentration at Day 15	8.00 ng/mL Standard Deviation 2.83	6.67 ng/mL Standard Deviation 2.08	—	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 29

TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=2 Participants 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.	CP-690,550 15 mg, Stage 1 n=3 Participants 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.	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.	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.
Tacrolimus (TAC) Plasma Trough Concentration at Day 29	7.00 ng/mL Standard Deviation 2.83	12.67 ng/mL Standard Deviation 4.51	—	—

PRIMARY outcome

Timeframe: 0 hour (pre-dose) on Day 57

TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg, Stage 1 n=2 Participants 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.	CP-690,550 15 mg, Stage 1 n=3 Participants 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.	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.	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.
Tacrolimus (TAC) Plasma Trough Concentration at Day 57	5.00 ng/mL Standard Deviation 1.41	6.33 ng/mL Standard Deviation 0.58	—	—

Adverse Events

Placebo, Stage 1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

CP-690,550 5 mg, Stage 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

CP-690,550 15 mg, Stage 1

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

CP-690,550 30 mg, Stage 1 And 2

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo, Stage 1 n=6 participants at risk 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.	CP-690,550 5 mg, Stage 1 n=6 participants at risk 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.	CP-690,550 15 mg, Stage 1 n=6 participants at risk 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.	CP-690,550 30 mg, Stage 1 And 2 n=10 participants at risk 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.
Infections and infestations Gastroenteritis	0.00% 0/6 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.	0.00% 0/6 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.	33.3% 2/6 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.	0.00% 0/10 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.
Infections and infestations Urinary tract infection	16.7% 1/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/10 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.
Infections and infestations Viral infection	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	10.0% 1/10 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.
Investigations Blood creatinine increased	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/10 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.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	10.0% 1/10 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.

Other adverse events

Additional Information

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Results disclosure agreements

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