| Primary | Percentage of Participants Who Were Positive for de Novo DSA (dnDSA) or Immune Activation (IA) Occurrence | DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching mean fluorescence intensity (MFI)=1000 at any time during the study. IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants. | The Modified Full Analysis Set (mFAS) consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Logistic regression with DSA/IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant calculated panel reactivity antibody (cPRA) as fixed effects, and pooled site as a random effect with standard variance components covariance type. | Regression, Logistic | | 0.5777 | | Odds Ratio (OR) | 1.115 | | | 2-Sided | 95 | 0.760 | 1.636 | | | | | Superiority | | |
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| Secondary | Percentage of Participants Who Were Positive, Negative or Indeterminate for dnDSA Occurrence | DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching MFI=1000 at any time during the study. Indeterminate was defined as MFI signal was >1000 and DSA was suspected, but could not be confirmed due to inadequate donor typing. Participants whose samples for the test were not available were reported as unknown. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Peak Mean Fluorescence Intensity (MFI) of DSA Positive Participants | Peak MFI of DSA positive participants was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for dnDSA were included in the analyses. | Posted | | Median | Full Range | fluorescence intensity unit | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of DSA Positive Participants With Weak, Moderate and Strong Antibody Strentgh | DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching MFI=1000 at any time during the study. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for dnDSA were included in the analyses. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of DSA Positive Participants With DSA Persistence | DSA was regarded as persistent under the following conditions: (i) DSA was detected and remained above the threshold for positivity (MFI = 1000) for two consecutive or nonconsecutive measurements, or (ii) the new appearance of a DSA at the threshold for positivity when preceded by a DSA of a different specificity that had subsequently become non-detectable. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for dnDSA were included in the analyses. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants Who Were Positive or Negative for Complement Component 1, Q Subcomponent (C1q)-Binding DSA | Percentage of participants who were positive or negative for C1q-binding DSA were reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants Who Were Positive or Negative for DSA Immunoglobulin G (IgG3) Isotype | Percentage of participants who were positive or negative for IgG3 isotype were reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of DSA Positive Participants With Human Leukocyte Antigen, Class II, DQ Locus (HLA-DQ) | Percentage of DSA positive participants with HLA-DQ Class-II were reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for DSA were included in the analyses. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants Who Were Positive for IA Occurrence From Day 1 to Day 365 Visit | IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From day 1 to day 365 visit | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants Who Were Positive for IA Occurrence From Day 30 to Day 365 Visit | IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From day 30 to day 365 visit | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With IA Persistence | IA was regarded as persistent under the following conditions: (i) IA was detected and remained above the threshold for positivity for two consecutive or non-consecutive measurements, or (ii) the new appearance of an IA at the threshold for positivity when preceded by an IA of a different specificity that had subsequently become non-detectable. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Presence of Transplant Glomerulopathy (TG) on Biopsy | TG was defined as chronic glomerulopathy (cg) >0 on centrally-interpreted institutional protocol biopsy or biopsy obtained for cause during the first year post-transplant with +2 months visit window. | The Biopsy Analysis Dataset (BAS) consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Presence of Microcirculatory Inflammation (MI) on Biopsy | MI was defined as glomerulitis (g) + peritubular capillaritis (ptc)>=2 on centrally-interpreted institutional protocol biopsy or biopsy obtained for cause during the first year post-transplant, with +2 months visit window. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Presence of Interstitial Fibrosis and Tubular Atrophy (IFTA) and Inflammation on Biopsy | IFTA and inflammation was defined as IFTA positive and inflammation positive (i >0) on centrally-interpreted institutional protocol biopsy or biopsy obtained for cause during the first year posttransplant, with +2 months visit window. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Threshold of <30 Millimetre Per Minute Per 1.73 Meter Square (mL/Min/1.73m^2) | The eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | At 1 year post transplant | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With eGFR Threshold of <40 mL/Min/1.73m^2 | The eGFR was calculated using the MDRD formula. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | At 1 year post transplant | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With eGFR Threshold of <50 mL/Min/1.73m^2 | The eGFR was calculated using the MDRD formula. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | At 1 year post transplant | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With a Five-point Decline in eGFR | The eGFR was calculated using the MDRD formula. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From 30 days post transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | eGFR at Day 30, Day 90, Day 180, Day 270 and Day 365 | The eGFR was calculated using the MDRD formula. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. mFAS population with available data at each time point. | Posted | | Mean | Standard Deviation | mL/min/1.73 m^2 | | Day 30, day 90, day 180, day 270 and day 365 | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Graft Loss | Graft loss was defined as re-transplantation, transplant nephrectomy, or a return to dialysis for at least a six week duration, or participants' death. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants Who Died | Percentage of participants who died were reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) | Positivity was determined by local biopsy, central pathology, or reported adverse events. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants Who Were Lost to Follow-up | Percentage of participants who were lost to follow-up were reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Either Graft Loss, Death, BPAR or Lost to Follow-up | Percentage of participants with either graft loss, death, BPAR or lost to follow-up were reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until 1 year | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Any Antibody-Mediated Rejection (ABMR) | Percentage of participants with ABMR were reported. Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. A positive assessment is defined as antibody mediated changes that are diagnosed as either acute ABMR or chronic active ABMR. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Normal Biopsy Findings | Percentage of participants with normal biopsy findings were reported. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With C4d Deposition Without Active Rejection | Percentage of participants with C4d deposition without active rejection were reported. | The BAS consisted of all mFAS participants who had at least 1 posttransplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Acute ABMR | Percentage of participants with acute ABMR were reported. | The BAS consisted of all mFAS participants who had at least 1 posttransplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
| |
| Secondary | Percentage of Participants With Grade I, II and III Acute ABMR | Percentage of participants with grade I, II and III acute ABMR were reported. Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Acute ABMR was graded as Grade I: acute tubular necrosis-like -like minimal inflammation, Grade II: Capillary and or glomerular inflammation (ptc/g >0) and/or thromboses, and Grade III: arterial - v3. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. Only those BAS participants who had acute AMBR were included in the analyses. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Chronic ABMR | Percentage of participants with chronic ABMR were reported. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
| |
| Secondary | Percentage of Participants With Borderline Changes | Percentage of participants with borderline changes were reported. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
| |
| Secondary | Percentage of Participants With Acute T-cell Mediated Rejection (TCMR) | Percentage of participants with acute TCMR were reported. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
| |
| Secondary | Percentage of Participants With Chronic TCMR | Percentage of participants with chronic TCMR were reported. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. Only those BAS participants who had TCMR were included in the analyses. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
| |
| Secondary | Percentage of Participants With Grade I, II and III IFTA | Percentage of participants with Grade I, II and III IFTA were reported. Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. IFTA was graded as Grade I: mild interstitial fibrosis and tubular atrophy (<25% of cortical area), Grade II: moderate interstitial fibrosis and tubular atrophy (26-50% of cortical area), and Grade III: severe interstitial fibrosis and tubular atrophy/ loss (>50% of cortical area). | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Any Additional Findings | Percentage of participants with any additional findings (other than Normal biopsy, borderline changes, acute and chronic ABMR, Grade I, II, and III ABMR, C4D deposition, acute and chronic TCMR, Grade I, II, and III TCMR, Grade I, II and III IFTA, acute tubular necrosis, interstitial nephritis, pyelonephritis, bk virus, calcineurin inhibitor toxicity, hemolytic uremic syndrome and recurrent disease) were reported. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Glomerulitis (g) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No glomerulitis, Score 1= <25% glomerulitis, Score 2= 25 to 75% glomerulitis and Score 3= >75% glomerulitis. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Tubulitis (t) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No mononuclear cells in tubules or single focus of tubulitis only, Score 1= Foci with 1 to 4 mononuclear cells/tubular cross section (or 10 tubular cells), Score 2= Foci with 5 to 10 mononuclear cells/tubular cross section (or 10 tubular cells) and Score 3= Foci with >10 mononuclear cells/tubular cross section or the presence of ≥2 areas of tubular basement membrane destruction accompanied by i2/i3 inflammation and t2 elsewhere. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID |
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| Secondary | Percentage of Participants With Intimal Arteritis (v) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No arteritis, Score 1= Mild to moderate intimal arteritis in at least 1 arterial cross section, Score 2= Severe intimal arteritis with at least 25% luminal area lost in at least 1 arterial cross section and Score 3= Transmural arteritis and/or arterial fibrinoid change and medial smooth muscle necrosis with lymphocytic infiltrate in vessel. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | Percentage of Participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | |
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| Secondary | Percentage of Participants With Mononuclear Cell Interstitial Inflammation (i) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No inflammation or in less than 10% of unscarred cortical parenchyma, Score 1= Inflammation in 10 to 25% of unscarred cortical parenchyma, Score 2= Inflammation in 26 to 50% of unscarred cortical parenchyma and Score 3= Inflammation in more than 50% of unscarred cortical parenchyma. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | |
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| Secondary | Percentage of Participants With Glomerular Basement Membrane Double Contours (cg) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No GBM double contours by light microscopy (LM) or electron microscopy (EM), Score 1= No GBM double contours by LM but GBM double contours (incomplete or circumferential) in at least 3 glomerular capillaries by EM or Double contours of the GBM in 1-25% of capillary loops in the most affected nonsclerotic glomerulus by LM , Score 2= Double contours affecting 26 to 50% of peripheral capillary loops in the most affected-glomerulus and Score 3= Double contours affecting more than 50% of peripheral capillary loops in the most affected-glomerulus. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
|
| Secondary | Percentage of Participants With Tubular Atrophy (ct) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No tubular atrophy, Score 1= Tubular atrophy involving up to 25% of the area of cortical tubules, Score 2= Tubular atrophy involving 26 to 50% of the area of cortical tubules and Score 3= Tubular atrophy involving in >50% of the area of cortical tubules. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
|
| Secondary | Percentage of Participants With Interstitial Fibrosis (ci) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= Interstitial fibrosis in up to 5% of cortical area, Score 1= Interstitial fibrosis in 6 to 25%of cortical area (mild interstitial fibrosis), Score 2= Interstitial fibrosis in 26 to 50% of cortical area (moderate interstitial fibrosis) and Score 3= Interstitial fibrosis in >50% of cortical area (severe interstitial fibrosis). | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | |
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| Secondary | Percentage of Participants With Vascular Fibrous Intimal Thickening (cv) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No chronic vascular changes, Score 1= Vascular narrowing of up to 25% luminal area by fibrointimal thickening, Score 2= Vascular narrowing of 26 to 50% luminal area by fibrointimal thickening and Score 3= Vascular narrowing of more than 50% luminal area by fibrointimal thickening. | The BAS consisted of all mFAS participants who had atleast 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | |
|
| Secondary | Percentage of Participants With Arteriolar Hyalinosis (ah) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No periodic acid-Schiff (PAS)-positive hyaline arteriolar thickening, Score 1= Mild to moderate PAS-positive hyaline thickening in at least 1 arteriole, Score 2= Moderate to severe PAS-positive hyaline thickening in more than 1 arteriole and Score 3= Severe PAS-positive hyaline thickening in many arterioles. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | |
|
| Secondary | Percentage of Participants With Peritubular Capillaritis (Ptc) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= Maximum number of leukocytes <3, Score 1= At least 1 leukocyte cell in ≥10% of cortical PTCs with 3-4 leukocytes in most severely involved PTC, Score 2= At least 1 leukocyte in ≥10% of cortical PTC with 5-10 leukocytes in most severely involved PTC and Score 3= At least 1 leukocyte in ≥10% of cortical PTC with >10 leukocytes in most severely involved PTC. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID |
|
| Secondary | Percentage of Participants With Mesangial Matrix Expansion (mm) Biopsy Score Assessed Using Banff Lesion Scores | Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. [Roufosse C et. al 2018]. Here, Score 0= No more than mild mesangial matrix increase in any glomerulus, Score 1= At least moderate mesangial matrix increase in up to 25% of nonsclerotic glomeruli, Score 2= At least moderate mesangial matrix increase in 26% to 50% of nonsclerotic glomeruli and Score 3= At least moderate mesangial matrix increase in >50% of nonsclerotic glomeruli. | The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. | Posted | | Number | | percentage of participants | | From date of transplant until month 14 | | | | ID | Title | Description |
|---|
| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID |
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| Secondary | Time to First Occurrence of DSA | DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching MFI=1000 at any time during the study. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of HLA-DQ DSA | Time to first occurrence of HLA-DQ DSA was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of C1q-binding DSA | Time to first occurrence of C1q-binding DSA was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of DSA IgG3 Isotype | Time to first occurrence of DSA IgG3 isotype was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of IA | Time to first occurrence of IA was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of TG on Biopsy | Time to first occurrence of TG on biopsy was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to Occurrence of Death | Time to occurrence of death was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Median | 95% Confidence Interval | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of Local BPAR | Time to first occurrence of local BPAR was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of Acute Forms of ABMR | Time to first occurrence of acute forms of ABMR was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of Chronic Forms of ABMR | Time to first occurrence of chronic forms of ABMR was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of Acute TCMR | Time to first occurrence of acute TCMR was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of Chronic TCMR | Time to first occurrence of chronic TCMR was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of Borderline Changes | Time to first occurrence of borderline changes was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Time to First Occurrence of IFTA | Time to first occurrence of IFTA was reported. | The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. | Posted | | Mean | Standard Deviation | days | | From date of transplant until 1 year | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death | A TEAE was defined as an Adverse Event (AE) observed on or after the day of starting the administration of the test drug/comparative drug. | The Safety Analysis Set (SAF) consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables. | Posted | | Number | | percentage of participants | | From first dose of study drug up to 7 days after last dose of study drug (up to 2 years) | | | | ID | Title | Description |
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| OG000 | Tacrolimus, Extended Release (Astagraf XL®) Once Daily | Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. | | OG001 | Tacrolimus, Immediate Release BID | Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study. |
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