Trial Outcomes & Findings for Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients (NCT NCT01624948)
NCT ID: NCT01624948
Last Updated: 2016-08-15
Results Overview
composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
3 months post-randomization
Results posted on
2016-08-15
Participant Flow
Participant milestones
| Measure |
Everolimus+Tacrolimus/Prednisone
This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BK polyomavirus (BKV) infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)
n=20 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
52.18 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 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
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Donor Type
Living
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Donor Type
Standard Deceased
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Donor Type
ECD
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Transplant Number
First
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Transplant Number
Second
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Etiology of End Stage Renal Disease (ESRD)
Diabetes
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Etiology of End Stage Renal Disease (ESRD)
Hypertension
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Etiology of End Stage Renal Disease (ESRD)
GN
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Etiology of End Stage Renal Disease (ESRD)
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Calculated Panel Reactive Antibodies (cPRA)
|
14.4 Percentage of Potential Donors
STANDARD_DEVIATION 28.8 • n=5 Participants
|
25.5 Percentage of Potential Donors
STANDARD_DEVIATION 36.3 • n=7 Participants
|
19.93 Percentage of Potential Donors
STANDARD_DEVIATION 32.82 • n=5 Participants
|
|
Ureteral Stent at Transplant
Ureteral Stent Present
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Ureteral Stent at Transplant
No Ureteral Stent Present
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Renal Graft Function
Delayed Graft Function
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Renal Graft Function
Normal Graft Function
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post-randomizationcomposite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization
Outcome measures
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=20 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia
|
11 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 3 months post-randomizationA doubling of BK viremia levels or the development of BKV nephropathy in subjects enrolled in the experimental study arm will prompt a conversion to standard care therapy. We will closely monitor BKV levels in the urine and blood and assess renal function monthly, as per our usual standard of care. Based on BKV results as well as renal function, as assessed by serum Cr, biopsies may be done for cause. Patients will have a final visit at month 4 to monitor for adverse events.
Outcome measures
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=20 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3 months post-randomizationPopulation: 19 patients enrolled in the immune-monitoring subset; 1 participant did not have a 3-month assay.
Outcome measures
| Measure |
Everolimus+Tacrolimus/Prednisone
n=6 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=12 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
p70S6 Kinase Phosphorylation
|
5002 Mean Fluorescence Intensity
Interval 1821.0 to 8389.0
|
4353 Mean Fluorescence Intensity
Interval 2676.0 to 6442.0
|
SECONDARY outcome
Timeframe: 3 months post-randomizationOutcome measures
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=20 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
Cholesterol
|
212 mg/dL
Standard Deviation 56.8
|
170 mg/dL
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: 3 months post-randomizationOutcome measures
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=20 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
Proteinuria
|
0.16 g/g creatinine
Standard Deviation .1
|
0.23 g/g creatinine
Standard Deviation .21
|
SECONDARY outcome
Timeframe: 3 months post-randomizationPopulation: a subset of 19 participants enrolled in the immune-monitoring portion of the study
Measurement of the expression of three NFAT-regulated genes IL-2, interferon gamma, and GM-CSF, to predict a rejection episode. The residual gene expression after Tacrolimus intake was calculated as T1.5/T0\*100, where T0 is the adjusted number of transcripts at Tacrolimus pre-dose level and T1.5 is the number of transcripts 1.5 hours after drug intake. For all three genes the residual expression was averaged and presented as "MRE of NFAT-regulated genes."
Outcome measures
| Measure |
Everolimus+Tacrolimus/Prednisone
n=3 Participants
This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=16 Participants
This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
|
|---|---|---|
|
Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes
|
46.35 percent residual expression
Interval -16.0 to 94.82
|
29.12 percent residual expression
Interval 20.83 to 41.34
|
Adverse Events
Everolimus+Tacrolimus/Prednisone
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Standard of Care: 50% Reduction of MPA
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 participants at risk
Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=20 participants at risk
Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
|
|---|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
CMV Pnemonia/Viremia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Immune system disorders
Acute Cellular Rejection (Grade 1)
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia and shortness of breath
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Sepsis/UTI
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Endocrine disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Other adverse events
| Measure |
Everolimus+Tacrolimus/Prednisone
n=20 participants at risk
Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
|
Standard of Care: 50% Reduction of MPA
n=20 participants at risk
Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
|
|---|---|---|
|
Gastrointestinal disorders
GI Upset
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Infections and infestations
UTI
|
10.0%
2/20 • Number of events 2
|
10.0%
2/20 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
BK Viremia allograft nephropathy
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Edema
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Herpes Simplex 1 Oral Ulcer
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Transaminitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
Acute kidney injury with chest pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Immune system disorders
Borderline Rejection
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Insomnia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Nightsweats
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Endocrine disorders
Hyperlipidemia
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Infections and infestations
CMV Viremia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place