Trial Outcomes & Findings for Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients (NCT NCT02103855)

NCT ID: NCT02103855

Last Updated: 2017-08-28

Results Overview

Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline and 1 year
• Results posted on: 2017-08-28

Participant Flow

First patient enrolled and started on June 3, 2014. Last patient enrolled and started on Aug 6, 2014. All patients enrolled at Indiana University Hospital - Transplant Unit.

Participants were enrolled according to inclusion and exclusion criteria. Tacrolimus was weaned according to protocol.

Participant milestones

Measure	Belatacept Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

Baseline characteristics by cohort

Measure	Belatacept n=6 Participants Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 year

Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept

Outcome measures

Measure	Belatacept n=4 Participants Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)	2.25 ml/min/1.73m2 Standard Deviation 3.35

PRIMARY outcome

Timeframe: 1 year

Population: 4 subjects who completed 1 year of Belatacept were analyzed.

Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.

Outcome measures

Measure	Belatacept n=4 Participants Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Serum Creatinine at Year 1	1.8 mg/dl Standard Deviation 0.2

SECONDARY outcome

Timeframe: 1 year

Pancreas Rejection as measured by serum amylase, serum lipase.

Outcome measures

Measure	Belatacept n=4 Participants Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Number of Participants With Pancreas Transplant Rejection	2 Participants

SECONDARY outcome

Timeframe: Baseline and 1 year

Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.

Outcome measures

Measure	Belatacept n=6 Participants Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Change From Baseline Serum Hemoglobin A1c	5.9 percentage of glycosylated hemoglobin Standard Deviation 0.15

SECONDARY outcome

Timeframe: 1 Year

Population: 4 subjects who completed 1 year of Belatacept.

Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.

Outcome measures

Measure	Belatacept n=4 Participants Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.	96.9 mg/dl Standard Deviation 6.3

Adverse Events

Belatacept

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Belatacept n=6 participants at risk Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1

Other adverse events

Measure	Belatacept n=6 participants at risk Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Belatacept
Gastrointestinal disorders Nausea	83.3% 5/6 • Number of events 5
Cardiac disorders Hypertension	33.3% 2/6 • Number of events 2
Endocrine disorders Hyperlipidemia	16.7% 1/6 • Number of events 1
Endocrine disorders Hot Flash	16.7% 1/6 • Number of events 1
Blood and lymphatic system disorders Anemia	50.0% 3/6 • Number of events 3
Infections and infestations Infection	50.0% 3/6 • Number of events 3
Renal and urinary disorders Hypokalemia	16.7% 1/6 • Number of events 1
Skin and subcutaneous tissue disorders Skin Sores	16.7% 1/6 • Number of events 1
Eye disorders Retinal Vessel Rupture	16.7% 1/6 • Number of events 1
Renal and urinary disorders Dehydration	16.7% 1/6 • Number of events 2
Skin and subcutaneous tissue disorders Hair Loss	16.7% 1/6 • Number of events 1

Additional Information

Jeanne Chen

Indiana University

Phone: 317-944-3570

Email: jchen@iuhealth.org

Results disclosure agreements

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