Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients (NCT NCT02921789)
NCT ID: NCT02921789
Last Updated: 2024-12-04
Results Overview
rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
At 3 Months post transplant
Results posted on
2024-12-04
Participant Flow
Participants were enrolled across multiple sites in Canada and USA. A total of 67 participants were randomized but 63 participants underwent a kidney transplant and received study drug.
Male or female participants with ≥ 18 years of age who were recipient of a de novo kidney from a living or deceased donor and has biopsy proven, primary focal segmental glomerulosclerosis (pFSGS) as a cause of ESRD in their native kidneys and their most current graft failure(s) was due to biopsy-proven, recurrent focal segmental glomerulosclerosis (rFSGS).
Participant milestones
| Measure |
Standard of Care (SOC) Regimen
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20 milligrams (mg) administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1 gram (g) administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 milligram per kilogram per day (mg/kg/day) (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 nanogram per milliliter (ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
29
|
|
Overall Study
Randomized and Took Study Drug
|
34
|
29
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
Standard of Care (SOC) Regimen
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20 milligrams (mg) administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1 gram (g) administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 milligram per kilogram per day (mg/kg/day) (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 nanogram per milliliter (ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Miscellaneous
|
3
|
2
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
SOC Regimen
n=34 Participants
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=29 Participants
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
41.9 Years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
40.5 Years
STANDARD_DEVIATION 13.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of Kidney Transplants
Number of kidney transplants = 1
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Number of Kidney Transplants
Number of kidney transplants = 2
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 3 Months post transplantPopulation: The Full Analysis Set (FAS) consisted of all participants who are randomized, receive at least one dose of study drug and receive a transplanted kidney. Participants who were later confirmed to have secondary FSGS were excluded from the FAS population because they were not at risk for recurrence post-transplant. Participants with available data at specified time point were included.
rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.
Outcome measures
| Measure |
SOC Regimen
n=32 Participants
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=27 Participants
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant
|
31.3 Percentage of participants
Interval 16.1 to 50.0
|
18.5 Percentage of participants
Interval 6.3 to 38.1
|
SECONDARY outcome
Timeframe: At 6 and 12 Months post transplantPopulation: FAS population with available data at specified time point.
rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.
Outcome measures
| Measure |
SOC Regimen
n=32 Participants
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=27 Participants
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant
Month 6
|
31.3 Percentage of participants
Interval 16.1 to 50.0
|
18.5 Percentage of participants
Interval 6.3 to 38.1
|
|
Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant
Month 12
|
35.5 Percentage of participants
Interval 19.2 to 54.6
|
23.1 Percentage of participants
Interval 9.0 to 43.6
|
SECONDARY outcome
Timeframe: At 3, 6 and 12 Months post transplantPopulation: FAS population with available data at specified time point.
All episodes of kidney dysfunction based on clinical signs and symptoms were evaluated for possible BPAR. BPAR was confirmed if participants Banff criteria \>=1.
Outcome measures
| Measure |
SOC Regimen
n=30 Participants
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=26 Participants
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant
Month 3
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
26.9 Percentage of participants
Interval 11.6 to 47.8
|
|
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant
Month 6
|
20.0 Percentage of participants
Interval 7.7 to 38.6
|
26.9 Percentage of participants
Interval 11.6 to 47.8
|
|
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant
Month 12
|
24.1 Percentage of participants
Interval 10.3 to 43.5
|
29.2 Percentage of participants
Interval 12.6 to 51.1
|
SECONDARY outcome
Timeframe: 12 Months post transplantPopulation: FAS Population with available data.
Efficacy failure was defined as BPAR, death, graft loss or lost to follow-up through 12 months post transplant.
Outcome measures
| Measure |
SOC Regimen
n=32 Participants
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=27 Participants
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant
|
32.3 Percentage of participants
Interval 16.7 to 51.4
|
32.0 Percentage of participants
Interval 14.9 to 53.5
|
SECONDARY outcome
Timeframe: At 3, 6 and 12 Months post transplantPopulation: FAS population with available data at specified time point.
Percentage of participants with biopsy-proven rFSGS determined by a blinded central review of images from electron microscopy (EM) and slides for light microscopy (LM) by an independent pathologist.
Outcome measures
| Measure |
SOC Regimen
n=30 Participants
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=24 Participants
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant
Month 3
|
35.7 Percentage of participants
Interval 18.6 to 55.9
|
31.8 Percentage of participants
Interval 13.9 to 54.9
|
|
Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant
Month 6
|
36.7 Percentage of participants
Interval 19.9 to 56.1
|
30.4 Percentage of participants
Interval 13.2 to 52.9
|
|
Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant
Month 12
|
36.7 Percentage of participants
Interval 19.9 to 56.1
|
29.2 Percentage of participants
Interval 12.6 to 51.1
|
Adverse Events
SOC Regimen
Serious events: 16 serious events
Other events: 29 other events
Deaths: 0 deaths
Bleselumab Regimen
Serious events: 16 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOC Regimen
n=34 participants at risk
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=29 participants at risk
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Vascular disorders
Lymphocele
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Vascular disorders
Subclavian steal syndrome
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Cardiac disorders
Atrial flutter
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Cardiac disorders
Intracardiac mass
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Cardiac disorders
Nodal rhythm
|
2.9%
1/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
2.9%
1/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
General disorders
Pyrexia
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Immune system disorders
Kidney transplant rejection
|
14.7%
5/34 • Number of events 6 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Bacteraemia
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Cytomegalovirus infection
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Cytomegalovirus viraemia
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Diverticulitis
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Endocarditis
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Enterococcal bacteraemia
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Orchitis
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Peritonitis bacterial
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Septic shock
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Urinary tract infection bacterial
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Urosepsis
|
5.9%
2/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Exposure via father
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Urine protein/creatinine ratio increased
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Nervous system disorders
Essential tremor
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Nervous system disorders
Lacunar infarction
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Acute kidney injury
|
8.8%
3/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Hydronephrosis
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Renal haematoma
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Renal vein thrombosis
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
Other adverse events
| Measure |
SOC Regimen
n=34 participants at risk
Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
Bleselumab Regimen
n=29 participants at risk
Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.5%
9/34 • Number of events 9 • Day of transplant through 12 months post transplant
SAF population
|
27.6%
8/29 • Number of events 9 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.7%
5/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.6%
7/34 • Number of events 8 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.8%
4/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Polycythaemia
|
5.9%
2/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Cardiac disorders
Tachycardia
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Eye disorders
Vision blurred
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
2/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Abdominal distension
|
14.7%
5/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
3/34 • Number of events 7 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Constipation
|
20.6%
7/34 • Number of events 7 • Day of transplant through 12 months post transplant
SAF population
|
20.7%
6/29 • Number of events 6 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Diarrhoea
|
32.4%
11/34 • Number of events 15 • Day of transplant through 12 months post transplant
SAF population
|
27.6%
8/29 • Number of events 9 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Nausea
|
32.4%
11/34 • Number of events 11 • Day of transplant through 12 months post transplant
SAF population
|
20.7%
6/29 • Number of events 8 • Day of transplant through 12 months post transplant
SAF population
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
9/34 • Number of events 10 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
General disorders
Chest discomfort
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
General disorders
Fatigue
|
14.7%
5/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
General disorders
Oedema peripheral
|
11.8%
4/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
17.2%
5/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Immune system disorders
Kidney transplant rejection
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
BK virus infection
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Cytomegalovirus infection
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Epstein-Barr virus infection
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Escherichia urinary tract infection
|
11.8%
4/34 • Number of events 7 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
4/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Polyomavirus viraemia
|
14.7%
5/34 • Number of events 7 • Day of transplant through 12 months post transplant
SAF population
|
17.2%
5/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Urinary tract infection enterococcal
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Incision site pain
|
14.7%
5/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
17.2%
5/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
41.2%
14/34 • Number of events 18 • Day of transplant through 12 months post transplant
SAF population
|
34.5%
10/29 • Number of events 11 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
20.7%
6/29 • Number of events 8 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
17.2%
5/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Blood creatinine increased
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Histology abnormal
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Transaminases increased
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Investigations
Weight increased
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Gout
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
14.7%
5/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
23.5%
8/34 • Number of events 9 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
17.6%
6/34 • Number of events 8 • Day of transplant through 12 months post transplant
SAF population
|
20.7%
6/29 • Number of events 7 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
4/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
29.4%
10/34 • Number of events 11 • Day of transplant through 12 months post transplant
SAF population
|
20.7%
6/29 • Number of events 6 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
26.5%
9/34 • Number of events 10 • Day of transplant through 12 months post transplant
SAF population
|
20.7%
6/29 • Number of events 6 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
20.6%
7/34 • Number of events 9 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
17.6%
6/34 • Number of events 6 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
3/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Nervous system disorders
Headache
|
20.6%
7/34 • Number of events 8 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Nervous system disorders
Tremor
|
32.4%
11/34 • Number of events 12 • Day of transplant through 12 months post transplant
SAF population
|
27.6%
8/29 • Number of events 8 • Day of transplant through 12 months post transplant
SAF population
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Bladder spasm
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Dysuria
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
11.8%
4/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Haematuria
|
11.8%
4/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
13.8%
4/29 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Oliguria
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Renal and urinary disorders
Urinary retention
|
11.8%
4/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Number of events 4 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
2/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
3.4%
1/29 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.9%
1/34 • Number of events 1 • Day of transplant through 12 months post transplant
SAF population
|
6.9%
2/29 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.8%
3/34 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/34 • Day of transplant through 12 months post transplant
SAF population
|
10.3%
3/29 • Number of events 3 • Day of transplant through 12 months post transplant
SAF population
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • Number of events 2 • Day of transplant through 12 months post transplant
SAF population
|
17.2%
5/29 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
|
Vascular disorders
Hypotension
|
11.8%
4/34 • Number of events 5 • Day of transplant through 12 months post transplant
SAF population
|
0.00%
0/29 • Day of transplant through 12 months post transplant
SAF population
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER