Trial Outcomes & Findings for Anti-inflammatory Therapy to Improve Outcomes After TPIAT (NCT NCT02713997)

Results Overview

derived from times 0-5 minute C-peptide measures on glucose potentiated arginine stimulation at day 90 post-TPIAT

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

day 90

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Overall Study STARTED	16	14	13
Overall Study COMPLETED	16	14	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-inflammatory Therapy to Improve Outcomes After TPIAT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=16 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant	Total n=43 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	43 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 12.1 • n=5 Participants	40.8 years STANDARD_DEVIATION 12 • n=7 Participants	37.3 years STANDARD_DEVIATION 12.6 • n=5 Participants	38.5 years STANDARD_DEVIATION 12 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	40 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: day 90

derived from times 0-5 minute C-peptide measures on glucose potentiated arginine stimulation at day 90 post-TPIAT

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Maximal Acute C-peptide Response to Glucose (ACRmax)	1.06 ng/mL*min Standard Deviation 0.26	1.52 ng/mL*min Standard Deviation 0.28	1.29 ng/mL*min Standard Deviation 0.28

SECONDARY outcome

Timeframe: 1 year

derived from times 0- 5 minute C-peptide values from glucose potentiated arginine

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
ACRmax	1.16 ng/mL*min Standard Deviation 0.32	1.44 ng/mL*min Standard Deviation 0.33	1.88 ng/mL*min Standard Deviation 0.39

SECONDARY outcome

Timeframe: day 90

derived from times 0- 5 minute insulin values from glucose potentiated arginine

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Maximal Acute Insulin Response to Glucose (AIRmax)	24.85 mU/L*min Standard Deviation 6.26	34.96 mU/L*min Standard Deviation 6.99	30.43 mU/L*min Standard Deviation 6.72

SECONDARY outcome

Timeframe: 1 year

no insulin use for \>14 days

Outcome measures

Outcome measures
Measure	Standard Care n=16 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Insulin Independence	2 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: day 90

calculated by average daily insulin dose from 2 weeks of logs

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Insulin Dose (Unit/Day)	22.3 unit/day Standard Deviation 4.3	17.2 unit/day Standard Deviation 4.6	26 unit/day Standard Deviation 4.7

SECONDARY outcome

Timeframe: day 90, 1 year, 2 years

calculated as area under the curve from every 30 minute C-peptide values on mixed meal tolerance test (MMTT)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 90, 1 year, 2 years

calculated as area under the curve from every 30 minute glucose values on MMTT

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year, 2 years

no events meeting American Diabetes Association (ADA criteria for SHE day 28- 365, and day 365- 730 respectively with A1c value of \<7%

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: cumulative, through 2 year visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 year

derived from times 0- 5 minute C-peptide values from glucose potentiated arginine

Outcome measures

Outcome measures
Measure	Standard Care n=13 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=10 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=8 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
ACRmax	1.38 ng/mL*min Standard Deviation 0.45	2.03 ng/mL*min Standard Deviation 0.51	2.6 ng/mL*min Standard Deviation 0.57

SECONDARY outcome

Timeframe: 1 year

derived from times 0- 5 minute insulin values from glucose potentiated arginine

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Maximal Acute Insulin Response to Glucose (AIRmax)	28.4 mU/L*min Standard Deviation 9	37.2 mU/L*min Standard Deviation 9.4	44.6 mU/L*min Standard Deviation 11

SECONDARY outcome

Timeframe: 2 year

derived from times 0- 5 minute insulin values from glucose potentiated arginine

Outcome measures

Outcome measures
Measure	Standard Care n=13 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=10 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=8 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Maximal Acute Insulin Response to Glucose (AIRmax)	34.3 mU/L*min Standard Deviation 11.8	47.4 mU/L*min Standard Deviation 13.5	56.9 mU/L*min Standard Deviation 15.1

SECONDARY outcome

Timeframe: 2 year

no insulin use for \>14 days

Outcome measures

Outcome measures
Measure	Standard Care n=16 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=12 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Insulin Independence	2 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

calculated by average daily insulin dose from 2 weeks of logs

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Insulin Dose (Unit/Day)	15.7 unit/day Standard Deviation 3.8	12 unit/day Standard Deviation 4	24.4 unit/day Standard Deviation 4.4

SECONDARY outcome

Timeframe: 2 year

calculated by average daily insulin dose from 2 weeks of logs

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Insulin Dose (Unit/Day)	13 unit/day Standard Deviation 3.5	16.8 unit/day Standard Deviation 3.9	16.1 unit/day Standard Deviation 4.3

SECONDARY outcome

Timeframe: 90 days

calculated as area under the curve from every 30 minute C-peptide values on mixed meal tolerance test (MMTT)

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Area Under the Curve (AUC) C-peptide	186.6 ng/mL*min Standard Deviation 29.44	247.6 ng/mL*min Standard Deviation 30.47	171.9 ng/mL*min Standard Deviation 31.6

SECONDARY outcome

Timeframe: 1 year

calculated as area under the curve from every 30 minute C-peptide values on mixed meal tolerance test (MMTT)

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Area Under the Curve (AUC) C-peptide	192 ng/mL*min Standard Deviation 39	257 ng/mL*min Standard Deviation 40	223 ng/mL*min Standard Deviation 45

SECONDARY outcome

Timeframe: 2 year

calculated as area under the curve from every 30 minute C-peptide values on mixed meal tolerance test (MMTT)

Outcome measures

Outcome measures
Measure	Standard Care n=13 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=10 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=9 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Area Under the Curve (AUC) C-peptide	165 ng/mL*min Standard Deviation 39	276 ng/mL*min Standard Deviation 44	235 ng/mL*min Standard Deviation 47

SECONDARY outcome

Timeframe: 90 days

calculated as area under the curve from every 30 minute glucose values on MMTT

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
AUC Glucose	18404 mg/dL*min Standard Error 1245	18144 mg/dL*min Standard Error 1289	19734 mg/dL*min Standard Error 1338

SECONDARY outcome

Timeframe: 1 year

calculated as area under the curve from every 30 minute glucose values on MMTT

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
AUC Glucose	21099 mg/dL*min Standard Error 1558	20770 mg/dL*min Standard Error 1612	21712 mg/dL*min Standard Error 1819

SECONDARY outcome

Timeframe: 2 year

calculated as area under the curve from every 30 minute glucose values on MMTT

Outcome measures

Outcome measures
Measure	Standard Care n=13 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=10 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=9 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
AUC Glucose	21493 mg/dL*min Standard Error 1921	18040 mg/dL*min Standard Error 2190	21846 mg/dL*min Standard Error 2309

SECONDARY outcome

Timeframe: 1 year

no events meeting American Diabetes Association (ADA criteria for SHE day 28- 365)

Outcome measures

Outcome measures
Measure	Standard Care n=15 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Absence of Severe Hypoglycemia (SHE) With A1c <7%	11 Participants	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 2 year

no events meeting American Diabetes Association (ADA criteria for SHE day 28- 365)

Outcome measures

Outcome measures
Measure	Standard Care n=13 Participants Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=13 Participants Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=11 Participants Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
Absence of Severe Hypoglycemia (SHE) With A1c <7%	9 Participants	9 Participants	6 Participants

Adverse Events

Standard Care

Serious events: 12 serious events

Other events: 14 other events

Deaths: 0 deaths

Etanercept

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Alpha-1 Antitrypsin

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Care n=16 participants at risk Patients in the standard care arm will undergo the usual procedure of TPIAT with no ancillary therapies provided.	Etanercept n=14 participants at risk Patients in the etanercept arm will undergo the usual procedure of TPIAT with additional therapy of etanercept. etanercept: 50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT	Alpha-1 Antitrypsin n=13 participants at risk Patients in the alpha-1 antitrypsin arm will undergo the usual procedure of TPIAT with additional therapy of alpha-1 antitrypsin (Aralast NP) Alpha 1-Antitrypsin: 90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
General disorders abdominal infection	0.00% 0/16 • collected over 90 days for all AE and 1 year for SAE	7.1% 1/14 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	7.7% 1/13 • Number of events 2 • collected over 90 days for all AE and 1 year for SAE
General disorders abdominal pain	12.5% 2/16 • Number of events 3 • collected over 90 days for all AE and 1 year for SAE	14.3% 2/14 • Number of events 10 • collected over 90 days for all AE and 1 year for SAE	30.8% 4/13 • Number of events 4 • collected over 90 days for all AE and 1 year for SAE
General disorders diarrhea	6.2% 1/16 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	14.3% 2/14 • Number of events 3 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders ALT/AST elevated	6.2% 1/16 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/14 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders fever	12.5% 2/16 • Number of events 2 • collected over 90 days for all AE and 1 year for SAE	7.1% 1/14 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders heme: clot or bleed	6.2% 1/16 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	14.3% 2/14 • Number of events 3 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders hypotension	6.2% 1/16 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/14 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders kidney/bladder issue	0.00% 0/16 • collected over 90 days for all AE and 1 year for SAE	7.1% 1/14 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders metabolic and electrolyte abnormalities	12.5% 2/16 • Number of events 2 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/14 • collected over 90 days for all AE and 1 year for SAE	15.4% 2/13 • Number of events 2 • collected over 90 days for all AE and 1 year for SAE
General disorders MSK pain	0.00% 0/16 • collected over 90 days for all AE and 1 year for SAE	14.3% 2/14 • Number of events 2 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE
General disorders Nausea/Vomiting	6.2% 1/16 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/14 • collected over 90 days for all AE and 1 year for SAE	7.7% 1/13 • Number of events 1 • collected over 90 days for all AE and 1 year for SAE
General disorders other GI	18.8% 3/16 • Number of events 4 • collected over 90 days for all AE and 1 year for SAE	14.3% 2/14 • Number of events 4 • collected over 90 days for all AE and 1 year for SAE	23.1% 3/13 • Number of events 3 • collected over 90 days for all AE and 1 year for SAE
General disorders other infection	25.0% 4/16 • Number of events 5 • collected over 90 days for all AE and 1 year for SAE	28.6% 4/14 • Number of events 7 • collected over 90 days for all AE and 1 year for SAE	30.8% 4/13 • Number of events 5 • collected over 90 days for all AE and 1 year for SAE
General disorders respiratory disease	0.00% 0/16 • collected over 90 days for all AE and 1 year for SAE	14.3% 2/14 • Number of events 2 • collected over 90 days for all AE and 1 year for SAE	0.00% 0/13 • collected over 90 days for all AE and 1 year for SAE

Other adverse events

Additional Information

Melena Bellin

University of Minnesota

Phone: 612-625-4686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place