| Primary | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine [in milligrams per deciliter (mg/dL)])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen [BUN] concentration [mg/dL])^(-0.170) * (serum albumin concentration [in grams per dL (g/dL)])^(0.318). A normal GFR is >90 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mL/min/1.73 m^2 | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG002 | Tofacitinib 30-15-10 mg BID | Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
| | | Title | Denominators | Categories |
|---|
| Month 9 (n=18,14,12) | | | Title | Measurements |
|---|
| - OG00067.06± 19.79
- OG00165.99± 12.46
- OG00267.05± 13.63
|
| | Month 12 (n=16,14,12) |
| |
| Primary | Serum Creatinine Levels | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mg/dL | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Primary | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. | Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | |
|
| Primary | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (≥)30 days. | Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Primary | Percentage of Participants With Hypercholesterolemia | Hypercholesterolemia was defined as cholesterol levels >240 mg/dL or 6.2 mmol/L. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Primary | Percentage of Participants With Hypertriglyceridemia by Visit | Hypertriglyceridemia was defined as triglyceride levels of >200 mg/dL or 2.3 mmol/L. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Primary | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. | Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 |
|
| Primary | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason. | Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 |
|
| Secondary | Calculated GFR Using the Nankivell Equation (mL/Min) | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine [in millimoles per liter (mmol/L)]) plus (0.25*body weight [in kilograms (kg)]) minus (0.5*serum urea [mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea]) minus (100 per height [in meters] square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mL/min | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mL/min | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | |
|
| Secondary | Reciprocal of Serum Creatinine | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | dL/mg | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels ≥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose ≥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose ≥200 mg/dL during an OGTT (Oral Glucose Tolerance Test). | Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Total Cholesterol Levels by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mg/dL | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Low-Density Lipoprotein (LDL) Levels by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mg/dL | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | High-Density Lipoprotein (HDL) Levels by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mg/dL | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | ratio | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Ratio of Serum LDL Level to HDL Level by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | ratio | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Serum Triglyceride Levels by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mg/dL | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Calculated as number of copies per 500 mg DNA. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | number of copies/500 mg DNA | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and >1000 copies/PCR. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | number of copies/PCR | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 30-15-10 mg BID | Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only. | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 30-15-10 mg BID | Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'. | Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist. | FAS; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included. | | Posted | | Number | | percentage of participants | | Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999). | | Posted | | Number | | percentage of participants | | Months 12, 18, 24, 36, 48, 60, 72, 84, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss. | FAS; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for ≥6 consecutive weeks, or death. | FAS; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. | FAS; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist. | FAS; n=number of participants remaining at risk for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID |
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| Secondary | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | | | Posted | | Mean | Standard Deviation | cells/uL | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Hemoglobin A1c (HbA1c) Levels by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | % HbA1c | | Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Homeostatic Model Assessment (HOMA)-%B by Visit | HOMA-%B = (20 times [*] fasting serum insulin) divided by (/) (fasting serum glucose minus [-] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements. | Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit. | Posted | | Mean | Standard Deviation | %B | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement. | Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit. | Posted | | Mean | Standard Deviation | ratio of serum proinsulin to insulin | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin. | Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit. | Posted | | Mean | Standard Deviation | mg*h/dL | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin. | Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit. | Posted | | Mean | Standard Deviation | microU*h/mL | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | HOMA Insulin Resistance (IR) by Visit | HOMA-IR=fasting serum insulin*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement. | Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit. | Posted | | Mean | Standard Deviation | HOMA-IR | | Months 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Fasting Serum Glucose Levels (mg/dL) by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mg/dL | | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | ng/mL | | Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 30-15-10 mg BID | Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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| Secondary | Trough Levels of Tacrolimus (ng/mL) by Visit | | Safety population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | ng/mL | | Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98) | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
| |
| Secondary | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Safety population; n=number of participants in Safety Population per visit with non-missing value. | Posted | | Mean | Standard Deviation | score on a scale | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
|
| Secondary | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement. | Safety population; n=number of participants in Safety population per visit with non-missing value. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID |
|
| Secondary | SF-36 v2 Subscale Scores by Visit | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Safety population; n=number of participants in Safety Population per visit with non-missing value. | Posted | | Mean | Standard Deviation | scores on a scale | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | |
|
| Secondary | Change From Baseline in SF-36 v2 Subscale Scores by Visit | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement. | Safety population; n=number of participants in Safety Population per visit with non-missing value. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID |
|
| Secondary | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question "At the moment, how much do you suffer?" for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction. | Safety population; n=number of participants in Safety Population per visit with non-missing value. | Posted | | Mean | Standard Deviation | scores on a scale | | Months 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 |
|
| Secondary | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question "At the moment, how much do you suffer?" for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction. | Safety population; n=number of participants in Safety Population per visit with non-missing value. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Months 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID |
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| Secondary | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. | Safety population; n=number of participants in Safety Population per visit with non-missing value. | Posted | | Mean | Standard Deviation | events | | Months 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | Tacrolimus | Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | | OG001 | Tofacitinib 15-10-5 mg BID | Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. |
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