Trial Outcomes & Findings for Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients (NCT NCT04225988)
NCT ID: NCT04225988
Last Updated: 2024-07-10
Results Overview
To assess whether the occurence of biopsy-proven acute rejection within 12 months of transplant is comparable between HS patients maintained on Envarsus XR and immediate-release tacrolimus.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
12 months
Results posted on
2024-07-10
Participant Flow
Male and female HLA sensitized (HS) renal transplantation patients, 18 years of age and over, receiving a deceased or living donor kidney allograft may enter the study. Twenty patients will be enrolled at Cedars-Sinai Medical Center (CSMC) for this pilot study. Patients who discontinue the study prematurely will not be replaced.
Of the total 28 participants ages 18 and older screened, 20 were enrolled in this single-center, open-label, randomized controlled trial design pilot study.
Participant milestones
| Measure |
Extended-release Tacrolimus
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Extended-release Tacrolimus
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Extended-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 15.0200 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 11.6376 • n=7 Participants
|
47.85 years
STANDARD_DEVIATION 13.2000 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 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
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants who completed their 12 month visit were assessed.
To assess whether the occurence of biopsy-proven acute rejection within 12 months of transplant is comparable between HS patients maintained on Envarsus XR and immediate-release tacrolimus.
Outcome measures
| Measure |
Extended-release Tacrolimus
n=8 Participants
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Number of Participants With Biopsy-proven Acute Rejection
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants who completed their 12 month visit were assessed.
To assess the number of participants who developed a presence of de novo donor-specific antibodies developing between Envarsus XR-treated and immediate-release tacrolimus-treated HS recipients.
Outcome measures
| Measure |
Extended-release Tacrolimus
n=8 Participants
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Number of Participants With de Novo Donor-specific Antibodies
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants who completed their 12 month visit were assessed.
To assess the number of participants who had persistent pre-existing donor-specific antibodies at 12 months in the Envarsus XR-treated and immediate-release tacrolimus-treated groups.
Outcome measures
| Measure |
Extended-release Tacrolimus
n=8 Participants
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Number of Persistent Pre-existing Donor-specific Antibodies
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants who completed their 12 month visit were assessed.
To assess the mean eGFR (using the CKD-Epi equation) between Envarsus XR-treated and immediate-release tacrolimus-treated HS recipients.
Outcome measures
| Measure |
Extended-release Tacrolimus
n=8 Participants
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR; Chronic Kidney Disease (CKD)-Epi Equation)
|
58 ml/min/1.73 m2
Interval 50.0 to 74.0
|
59 ml/min/1.73 m2
Interval 38.0 to 67.0
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants who completed their 12 month visit were assessed.
To assess the mean percentage of donor-derived cell-free DNA (Allosure) between Envarsus XR-treated and immediate-release tacrolimus-treated HS recipients.
Outcome measures
| Measure |
Extended-release Tacrolimus
n=8 Participants
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 Participants
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Level of Donor-derived Cell-free DNA (Allosure)
12 Months
|
1.166 % donor-derived cell-free DNA
Standard Deviation 0.926
|
2.093 % donor-derived cell-free DNA
Standard Deviation 1.681
|
|
Level of Donor-derived Cell-free DNA (Allosure)
6 Months
|
0.599 % donor-derived cell-free DNA
Standard Deviation 0.688
|
1.343 % donor-derived cell-free DNA
Standard Deviation 1.180
|
Adverse Events
Extended-release Tacrolimus
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Immediate-release Tacrolimus
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended-release Tacrolimus
n=10 participants at risk
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 participants at risk
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Infections and infestations
Fever
|
20.0%
2/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Musculoskeletal and connective tissue disorders
Thoracic back pain
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Urosepsis
|
10.0%
1/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Acute hemorrhage
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Enterococcus bacteremia
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Pneumonia
|
20.0%
2/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Reproductive system and breast disorders
Vaginal abscess
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Transplant pyelonephritis
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Gastrointestinal disorders
Gastroenteritis
|
20.0%
2/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Endocrine disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Endocrine disorders
Post transplantation diabetes melitus (PTDM)
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Urinary tract infection (UTI)
|
20.0%
2/10 • Number of events 4 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Nausea and Vomiting
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Elevated serum creatinine
|
10.0%
1/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Secondary acute idney injury (AKI)
|
10.0%
1/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Blood and lymphatic system disorders
Hypogamma
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Abnormal labs
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
Other adverse events
| Measure |
Extended-release Tacrolimus
n=10 participants at risk
Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Extended-release tacrolimus: Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
|
Immediate-release Tacrolimus
n=10 participants at risk
Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.
Immediate-release tacrolimus: Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
|
|---|---|---|
|
Renal and urinary disorders
Increased Allosure
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Elevated serum creatinine
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
20.0%
2/10 • Number of events 2 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Nausea
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Dehydration
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Right lower quardrant abdominal pain
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Vomitting
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Hypotension
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
30.0%
3/10 • Number of events 3 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
BK Viremia
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Antibody-mediated rejection
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Wrist abscess
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Norcadia nova
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
General disorders
Hair loss
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
Cough
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Gastrointestinal disorders
Loose stools
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
10.0%
1/10 • Number of events 1 • 12 months
Adverse events and severe adverse events were collected and reported in all enrolled participants who received extended-release or immediate-release Tacrolimus.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place