Trial Outcomes & Findings for Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens (NCT NCT01653847)
NCT ID: NCT01653847
Last Updated: 2021-03-02
Results Overview
Evaluate the change in regulatory T cell generation and review the relationship of the newly generated T cells with their function in the two maintenance immunosuppressive regimens at baseline, 3 and 12 months post-transplant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Baseline, 3 months, and 12 months post-transplant
Results posted on
2021-03-02
Participant Flow
Donor participants were considered to be enrolled but were not part of our outcome analysis because their participation was only on the basis of providing blood for testing the immune system of the recipients.
Donor participants were considered to be enrolled but were not part of our outcome analysis because their participation was only on the basis of providing blood for testing the immune system of the recipients.
Participant milestones
| Measure |
Group 1: Tacrolimus With MMF.
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Tacrolimus With MMF.
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
Baseline characteristics by cohort
| Measure |
Group 1: Tacrolimus With MMF.
n=20 Participants
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 Participants
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 13 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 16 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 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
|
|
Pre-Emptive Transplant (Prior to Dialysis)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cause of End Stage Renal Disease
Hypertension
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cause of End Stage Renal Disease
Polycystic Kidney Disease
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cause of End Stage Renal Disease
Lupus
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cause of End Stage Renal Disease
Diabetes
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Cause of End Stage Renal Disease
Unknown
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Induction Therapy History
Alemtuzumab
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Induction Therapy History
IL-2 Receptor Antagonist
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, and 12 months post-transplantPopulation: The percentage of Treg cells in peripheral blood is shown below per group.
Evaluate the change in regulatory T cell generation and review the relationship of the newly generated T cells with their function in the two maintenance immunosuppressive regimens at baseline, 3 and 12 months post-transplant.
Outcome measures
| Measure |
Group 1: Tacrolimus With MMF.
n=20 Participants
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 Participants
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Change in T Cell & B Cell Generation
Baseline
|
1.05 Mean % of Treg cells in peripheral blood
Standard Deviation 0.17
|
0.93 Mean % of Treg cells in peripheral blood
Standard Deviation 0.13
|
|
Change in T Cell & B Cell Generation
3 Months
|
0.8 Mean % of Treg cells in peripheral blood
Standard Deviation 0.19
|
1.12 Mean % of Treg cells in peripheral blood
Standard Deviation 0.13
|
|
Change in T Cell & B Cell Generation
12 Months
|
0.81 Mean % of Treg cells in peripheral blood
Standard Deviation 0.10
|
1.18 Mean % of Treg cells in peripheral blood
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: 3 months, 6 months, and 12 months post-transplantEvaluate the change in graft function (as measured by GFR) at 12 months post-transplant from baseline.
Outcome measures
| Measure |
Group 1: Tacrolimus With MMF.
n=19 Participants
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 Participants
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Change in Glomerular Filtration Rate (GFR)
3 months
|
63 ml/minutes per 1.73 meters^2
Standard Deviation 19
|
66 ml/minutes per 1.73 meters^2
Standard Deviation 22
|
|
Change in Glomerular Filtration Rate (GFR)
6 months
|
64 ml/minutes per 1.73 meters^2
Standard Deviation 19
|
64 ml/minutes per 1.73 meters^2
Standard Deviation 24
|
|
Change in Glomerular Filtration Rate (GFR)
12 months
|
65 ml/minutes per 1.73 meters^2
Standard Deviation 20
|
72 ml/minutes per 1.73 meters^2
Standard Deviation 21
|
SECONDARY outcome
Timeframe: baseline - 24 months post transplantThe number of patients who were alive at 2 years post transplant
Outcome measures
| Measure |
Group 1: Tacrolimus With MMF.
n=20 Participants
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 Participants
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Patient Survival
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 months post-transplantThe number of subjects with renal allograft survival.
Outcome measures
| Measure |
Group 1: Tacrolimus With MMF.
n=20 Participants
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 Participants
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Renal Allograft Survival
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 months post transplantNumber of subjects who experience acute rejection of the renal allograft.
Outcome measures
| Measure |
Group 1: Tacrolimus With MMF.
n=20 Participants
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 Participants
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Acute Rejection
|
4 Participants
|
0 Participants
|
Adverse Events
Group 1: Tacrolimus With MMF.
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2: Tacrolimus With Everolimus
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Tacrolimus With MMF.
n=20 participants at risk
This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.
Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
|
Group 2: Tacrolimus With Everolimus
n=20 participants at risk
This group will receive a low dose Tacrolimus with concentration controlled Everolimus
Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is \< 3 ng/mL, or reduced if the trough level is \> 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.0%
1/20 • 2 years
|
15.0%
3/20 • 2 years
|
|
Infections and infestations
Polyomavirus nephropathy
|
5.0%
1/20 • 2 years
|
0.00%
0/20 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • 2 years
|
0.00%
0/20 • 2 years
|
|
Infections and infestations
Other Infection
|
15.0%
3/20 • 2 years
|
25.0%
5/20 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place