Kidney Transplant; Complications
Conditions
Keywords
Immunosuppression
Brief summary
The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability, and lower biopsy proven rejection.
Interventions
DRUGOnce daily immunosuppression regimen
Intervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen.
DRUGTwice daily immunosuppression regimen
This is the arm which we are designating the standard, which will be the comparison to the active drug arm.
Sponsors
Veloxis Pharmaceuticals
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 18 years old * Kidney transplant recipient * Thymoglobulin induction
Exclusion criteria
* Non-renal organ transplant * Combined organ transplant * Inability to receive Envarsus after transplant * Discharged to acute care facility after transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3 months and 12 months post transplant | BAASIS Survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3 months and 12 months post transplant | Pill Manager (personal medication record keeping for those who participants who choose to use this method of recording their self-administered medication) |
| Composite Endpoint Measurement | 12 months | Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Once Daily Regimen Once daily medication regimen (Envarsus and azathioprine)
Once daily immunosuppression regimen: Intervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen. | 23 |
| Twice Daily Regimen Twice daily medication regimen (Tacrolimus and mycophenolic acid)
Twice daily immunosuppression regimen: This is the arm which we are designating the standard, which will be the comparison to the active drug arm. | 24 |
| Total | 47 |
Baseline characteristics
| Characteristic | Once Daily Regimen | Total | Twice Daily Regimen |
|---|---|---|---|
| Age, Continuous | 57.58 years STANDARD_DEVIATION 12.3 | 56.55 years STANDARD_DEVIATION 12.24 | 55.6 years STANDARD_DEVIATION 14.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 34 Participants | 19 Participants |
| Region of Enrollment United States | 23 participants | 47 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 21 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 26 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 23 | 0 / 24 |
| other Total, other adverse events | 1 / 23 | 1 / 24 |
| serious Total, serious adverse events | 9 / 23 | 13 / 24 |
Outcome results
Primary
Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
BAASIS Survey
Time frame: 3 months and 12 months post transplant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q1 Do you recall not having taken your immunosuppressive meds some times in the past 4 weeks? | 1 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q2 Have you skipped several consecutive doses of immunosuppressive meds in the past 4 weeks? | 0 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q3 Do you recall taking immunos meds with >2hrs from the prescribed time in the past 4 weeks? | 9 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q4 Have you reduced the prescribed amount of immunosuppressive meds during the past 4 weeks? | 1 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12month:Q1 Do you recall not having taken your immunosuppressive meds some times in past 4 weeks? | 1 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12month:Q2 Have you skipped several consecutive doses of immunosuppressive meds in the past 4 weeks? | 0 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12mth:Q3 Do you recall taking immunos meds with >2hrs from the prescribed time in the past 4 weeks? | 3 participants |
| Once Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12month:Q4 Have you reduced the prescribed amount of immunosuppressive meds during the past 4 weeks? | 0 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12month:Q4 Have you reduced the prescribed amount of immunosuppressive meds during the past 4 weeks? | 0 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q1 Do you recall not having taken your immunosuppressive meds some times in the past 4 weeks? | 2 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12month:Q1 Do you recall not having taken your immunosuppressive meds some times in past 4 weeks? | 2 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q2 Have you skipped several consecutive doses of immunosuppressive meds in the past 4 weeks? | 0 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12mth:Q3 Do you recall taking immunos meds with >2hrs from the prescribed time in the past 4 weeks? | 6 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q3 Do you recall taking immunos meds with >2hrs from the prescribed time in the past 4 weeks? | 5 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 12month:Q2 Have you skipped several consecutive doses of immunosuppressive meds in the past 4 weeks? | 1 participants |
| Twice Daily Regimen | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | 3month:Q4 Have you reduced the prescribed amount of immunosuppressive meds during the past 4 weeks? | 0 participants |
Secondary
Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months
Pill Manager (personal medication record keeping for those who participants who choose to use this method of recording their self-administered medication)
Time frame: 3 months and 12 months post transplant
Population: There are Zero 0 patients in study who used the pill manager during the study. No data were collected
Secondary
Composite Endpoint Measurement
Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Once Daily Regimen | Composite Endpoint Measurement | 1 participants |
| Twice Daily Regimen | Composite Endpoint Measurement | 1 participants |