Trial Outcomes & Findings for Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults (NCT NCT00078559)
NCT ID: NCT00078559
Last Updated: 2018-06-29
Results Overview
Number of acute rejections\[1\] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant) 1. Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Four years post-transplant
Results posted on
2018-06-29
Participant Flow
For this trial, one center in the United States enrolled ten eligible adult recipients of first kidney transplants (0-3 human leukocyte antigen (HLA)-antigen mismatch) from February 2005 to February 2006
At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form. Refer to inclusion and exclusion criteria section for more details
Participant milestones
| Measure |
Alemtuzumab
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Baseline characteristics by cohort
| Measure |
Alemtuzumab
n=10 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Glomerulonephritis
|
0 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Pyelonephritis/Interstitial Nephritis
|
0 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Cystic/Polycystic Kidney Disease
|
4 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Hypertension
|
0 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Diabetes Mellitus
|
1 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Obstructive/Reflux Nephropathy
|
1 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
IgA Nephropathy
|
2 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Post-streptococcal Glomerular Nephritis
|
0 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Systemic Lupus Erythematosus
|
0 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Etiology Uncertain
|
2 Participants
n=5 Participants
|
|
Primary Cause of Renal Failure
Other
|
0 Participants
n=5 Participants
|
|
Pre-Transplant Dialysis
Hemodialysis and Peritoneal Dialysis
|
0 Participants
n=5 Participants
|
|
Pre-Transplant Dialysis
Hemodialysis
|
5 Participants
n=5 Participants
|
|
Pre-Transplant Dialysis
Peritoneal Dialysis
|
0 Participants
n=5 Participants
|
|
Pre-Transplant Dialysis
Dialysis - Unknown Type
|
0 Participants
n=5 Participants
|
|
Pre-Transplant Dialysis
Participants without pre-transplant dialysis
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Four years post-transplantPopulation: Intent-to-treat
Number of acute rejections\[1\] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant) 1. Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=10 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Acute Rejections in All Enrolled Participants
|
1 Rejection Events
|
—
|
SECONDARY outcome
Timeframe: Transplantation to end of study (up to four years post-transplant)Population: Intent-to-treat
Following sirolimus withdrawal, the number of acute rejections\[1\] in all enrolled participants 1\] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. \[2\] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=10 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal
|
0 Rejection Events
|
—
|
SECONDARY outcome
Timeframe: Initiation of sirolimus to end of study (up to four years post-transplant)Population: Sirolimus withdrawal initiation participant sample
Acute rejections\[1\] between initiation of sirolimus withdrawal and end of study 1\] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. \[2\] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study
|
0 Rejection Events
|
—
|
SECONDARY outcome
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)Population: Participants for whom sirolimus withdrawal was not initiated
Time (days) to acute rejection\[1\] for participants where sirolimus was not initiated 1\] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. \[2\] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=1 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated
|
274 Days
|
—
|
SECONDARY outcome
Timeframe: Transplantation to acute rejection (up to one year post-transplant)Population: Participants with acute rejections for whom sirolimus withdrawal was not initiated
Time (days) to acute rejection\[1\] for participants occurring during the year following transplantation 1\] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. \[2\] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=1 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period
|
274 Days
|
—
|
SECONDARY outcome
Timeframe: Transplantation to Death (up to four years post-transplant)Population: Intent-to-treat
Participants who died during the study, all cause(s)
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Deaths Stratified by Sirolimus Withdrawal Status
|
0 deaths
|
0 deaths
|
SECONDARY outcome
Timeframe: Transplantation to Graft Loss (up to four years post-transplantation)Population: Intent-to-treat
Participants who experienced graft loss\[1\] during study \[1\]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Transplantation to severe acute rejection (up to four years post-transplantation)Population: Intent-to-treat
Participants who experienced severe acute rejections\[1\] during study 1. Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status
|
0 Rejection Events
|
0 Rejection Events
|
SECONDARY outcome
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)Population: Intent-to-treat
Participants who experienced acute rejection\[1\] during study which required anti-lymphocyte (OKT3, ATG) therapy 1\] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. \[2\] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Transplantation to end of study (up to four years post-transplant)Population: Intent-to-treat
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
|
2 adverse events
|
8 adverse events
|
SECONDARY outcome
Timeframe: Transplantation to end of study (up to four years post-transplant)Population: Intent-to-treat
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
|
0 adverse events
|
2 adverse events
|
SECONDARY outcome
Timeframe: Transplantation to end of study (up to four years post-transplant)Population: Intent-to-treat
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
|
2 adverse events
|
7 adverse events
|
SECONDARY outcome
Timeframe: Transplantation to end of study (up to four years post-transplant)Population: Intent-to-treat
Side effects of conventional immunosuppression include increased body weight and hypertension
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status
|
2 side effects
|
6 side effects
|
SECONDARY outcome
Timeframe: Transplantation to end of study (up to four years post-transplant)Population: Intent-to-treat
Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 - 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function
Outcome measures
| Measure |
Alemtuzumab
n=2 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
Alemtuzumab (Not Withdrawn From Sirolimus)
n=8 Participants
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
|
|---|---|---|
|
Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status
|
-4.2 mg/dL
Standard Deviation 2.3
|
-5.4 mg/dL
Standard Deviation 2.7
|
Adverse Events
Alemtuzumab
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alemtuzumab
n=10 participants at risk
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
10.0%
1/10 • Number of events 1
|
|
Immune system disorders
Transplant rejection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Escherichia sepsis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Gas gangrene
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pneumonia klebsiella
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
10.0%
1/10 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Alemtuzumab
n=10 participants at risk
Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose \[30 mg\]each day, Days 0 \[transplant day\], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started \<= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
80.0%
8/10 • Number of events 17
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
2/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
80.0%
8/10 • Number of events 14
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
10/10 • Number of events 10
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.0%
3/10 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
5/10 • Number of events 6
|
|
Cardiac disorders
Supraventricular extrasystoles
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Cushingoid
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10 • Number of events 3
|
|
Eye disorders
Abnormal sensation in eye
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Blepharospasm
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Vision blurred
|
20.0%
2/10 • Number of events 2
|
|
Eye disorders
Visual acuity reduced
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
60.0%
6/10 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal hernia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
6/10 • Number of events 14
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
70.0%
7/10 • Number of events 7
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Glossodynia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 10
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 5
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 7
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Generalised oedema
|
50.0%
5/10 • Number of events 6
|
|
General disorders
Infusion site extravasation
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Malaise
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Oedema
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Oedema peripheral
|
90.0%
9/10 • Number of events 19
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pyrexia
|
60.0%
6/10 • Number of events 11
|
|
General disorders
Xerosis
|
10.0%
1/10 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder polyp
|
10.0%
1/10 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst
|
10.0%
1/10 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
30.0%
3/10 • Number of events 5
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Chromoblastomycosis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus viraemia
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Escherichia urinary tract infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Eyelid folliculitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
10.0%
1/10 • Number of events 2
|
|
Infections and infestations
Gastroenteritis viral
|
30.0%
3/10 • Number of events 5
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Human polyomavirus infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Incision site cellulitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Klebsiella infection
|
20.0%
2/10 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pneumonia cryptococcal
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
40.0%
4/10 • Number of events 9
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
5/10 • Number of events 8
|
|
Infections and infestations
Urinary tract infection
|
20.0%
2/10 • Number of events 4
|
|
Infections and infestations
Urinary tract infection bacterial
|
20.0%
2/10 • Number of events 3
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
10.0%
1/10 • Number of events 2
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Back injury
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Chronic allograft nephropathy
|
20.0%
2/10 • Number of events 2
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
30.0%
3/10 • Number of events 3
|
|
Injury, poisoning and procedural complications
Dialysis device complication
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site complication
|
100.0%
10/10 • Number of events 12
|
|
Injury, poisoning and procedural complications
Incision site pain
|
100.0%
10/10 • Number of events 12
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Open wound
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Renal injury
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
6/10 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
5/10 • Number of events 7
|
|
Investigations
Blood creatinine increased
|
40.0%
4/10 • Number of events 6
|
|
Investigations
Blood lactate dehydrogenase increased
|
60.0%
6/10 • Number of events 7
|
|
Investigations
Breath sounds abnormal
|
100.0%
10/10 • Number of events 12
|
|
Investigations
Gamma-glutamyltransferase increased
|
40.0%
4/10 • Number of events 6
|
|
Investigations
Oxygen saturation decreased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Urine output decreased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Weight decreased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Weight increased
|
60.0%
6/10 • Number of events 8
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
4/10 • Number of events 4
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Gout
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
90.0%
9/10 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
2/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
60.0%
6/10 • Number of events 7
|
|
Metabolism and nutrition disorders
Increased appetite
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
20.0%
2/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Obesity
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
30.0%
3/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
3/10 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
5/10 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
40.0%
4/10 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
4/10 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
10.0%
1/10 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 6
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
30.0%
3/10 • Number of events 3
|
|
Nervous system disorders
Restless legs syndrome
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Tremor
|
20.0%
2/10 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Disorientation
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
60.0%
6/10 • Number of events 6
|
|
Renal and urinary disorders
Hydronephrosis
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Hydroureter
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Nephropathy toxic
|
30.0%
3/10 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
4/10 • Number of events 6
|
|
Renal and urinary disorders
Pyelocaliectasis
|
20.0%
2/10 • Number of events 2
|
|
Renal and urinary disorders
Renal infarct
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Ureteral disorder
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urethral stenosis
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
4/10 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
2/10 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
20.0%
2/10 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
10/10 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
5/10 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
60.0%
6/10 • Number of events 6
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Flushing
|
20.0%
2/10 • Number of events 2
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
60.0%
6/10 • Number of events 10
|
|
Vascular disorders
Hypotension
|
40.0%
4/10 • Number of events 4
|
|
Vascular disorders
Lymphocele
|
10.0%
1/10 • Number of events 1
|
Additional Information
Arjang Djamali, MD, MS, FASN
University of Wisconsin - Department of Medicine, Madison, Wisconsin
Phone: 608-262-7330
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place