Trial Outcomes & Findings for MGA031, Sirolimus and Tacrolimus in Islet Transplantation (NCT NCT00265473)

NCT ID: NCT00265473

Last Updated: 2017-03-09

Results Overview

Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: At one year after initial transplant.
• Results posted on: 2017-03-09

Participant Flow

Participant milestones

Measure	Experimental Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MGA031, Sirolimus and Tacrolimus in Islet Transplantation

Baseline characteristics by cohort

Measure	Experimental n=5 Participants Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: At one year after initial transplant.

Population: The number of participants was based on the participants that were actually transplanted.

Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.

Outcome measures

Measure	Experimental n=5 Participants Islet infusion
Subjects With Full Islet Function.	3 Participants

PRIMARY outcome

Timeframe: Day 0 - Day 365

Number of serious adverse events related to immunosuppressive therapy.

Outcome measures

Measure	Experimental n=5 Participants Islet infusion
Serious Adverse Events Related to Immunosuppressive Therapy.	0 Serious Adverse Events

SECONDARY outcome

Timeframe: At one year after initial transplant

Proportion of subjects with partial islet function and no episodes of severe hypoglycemia at one year after initial islet transplant.

Outcome measures

Measure	Experimental n=5 Participants Islet infusion
Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;	0 Participants

SECONDARY outcome

Timeframe: At 75 days after transplant

Proportion of insulin independent single-donor subjects at day 75 after transplant

Outcome measures

Measure	Experimental n=5 Participants Islet infusion
Insulin Independent Single-donor Subjects.	1 Participants

SECONDARY outcome

Timeframe: At one year after final transplant

Proportion of insulin independent multiple-donor subjects at one year after final transplant. Participant received more than one islet transplant.

Outcome measures

Measure	Experimental n=5 Participants Islet infusion
Insulin Independent Multiple-donor Subjects.	1 participants

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melena D. Bellin, MD

Schulze Diabetes Institute, University of Minnesota

Phone: 612-625-4686

Email: bell0130@umn.edu

Results disclosure agreements

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