Trial Outcomes & Findings for Once Daily Immunosuppression Regimen (NCT NCT03555448)

NCT ID: NCT03555448

Last Updated: 2025-01-22

Results Overview

BAASIS Survey

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: 3 months and 12 months post transplant
• Results posted on: 2025-01-22

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	25	26
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Once Daily Immunosuppression Regimen

Baseline characteristics by cohort

Measure	Once Daily Regimen n=23 Participants 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.	Twice Daily Regimen n=24 Participants 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.	Total n=47 Participants Total of all reporting groups
Age, Continuous	57.58 years STANDARD_DEVIATION 12.3 • n=5 Participants	55.6 years STANDARD_DEVIATION 14.3 • n=7 Participants	56.55 years STANDARD_DEVIATION 12.24 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 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	1 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	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	19 Participants n=7 Participants	34 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	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months and 12 months post transplant

BAASIS Survey

Outcome measures

Measure	Once Daily Regimen n=23 Participants 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.	Twice Daily Regimen n=24 Participants 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.
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	2 participants
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	0 participants
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	5 participants
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	0 participants
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	2 participants
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	1 participants
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	6 participants
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	0 participants

SECONDARY outcome

Timeframe: 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

Pill Manager (personal medication record keeping for those who participants who choose to use this method of recording their self-administered medication)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.

Outcome measures

Measure	Once Daily Regimen n=23 Participants 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.	Twice Daily Regimen n=24 Participants 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.
Composite Endpoint Measurement	1 participants	1 participants

Adverse Events

Once Daily Regimen

Serious events: 9 serious events

Other events: 1 other events

Deaths: 1 deaths

Twice Daily Regimen

Serious events: 13 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Once Daily Regimen n=23 participants at risk 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.	Twice Daily Regimen n=24 participants at risk 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.
Renal and urinary disorders AKI	8.7% 2/23 • Number of events 3 • 1 year from time of transplant	12.5% 3/24 • Number of events 3 • 1 year from time of transplant
Infections and infestations Infection	13.0% 3/23 • Number of events 4 • 1 year from time of transplant	12.5% 3/24 • Number of events 3 • 1 year from time of transplant
Renal and urinary disorders Urine leak	0.00% 0/23 • 1 year from time of transplant	4.2% 1/24 • Number of events 1 • 1 year from time of transplant
General disorders Hyperkalemia	4.3% 1/23 • Number of events 1 • 1 year from time of transplant	8.3% 2/24 • Number of events 2 • 1 year from time of transplant
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.3% 1/23 • Number of events 1 • 1 year from time of transplant	4.2% 1/24 • Number of events 1 • 1 year from time of transplant
Gastrointestinal disorders Nausea and vomiting/abdominal pain	17.4% 4/23 • Number of events 5 • 1 year from time of transplant	12.5% 3/24 • Number of events 3 • 1 year from time of transplant
Vascular disorders Transplant renal artery stenosis	4.3% 1/23 • Number of events 1 • 1 year from time of transplant	4.2% 1/24 • Number of events 1 • 1 year from time of transplant

Other adverse events

Measure	Once Daily Regimen n=23 participants at risk 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.	Twice Daily Regimen n=24 participants at risk 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.
Vascular disorders Dialysis access issue (clotting/bleeding)	4.3% 1/23 • Number of events 1 • 1 year from time of transplant	4.2% 1/24 • Number of events 1 • 1 year from time of transplant

Additional Information

R. Delos Santos

Washington University

Phone: 3143628351

Email: delossantos@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place