Islet Transplantation Using Abatacept

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Efalizumab

Efalizumab was a medication approved for use in psoriasis which was being explored to determine efficacy with immunosuppression following organ transplantation. Efalizumab was administered subcutaneously on a weekly basis. Upon efalizumab being withdrawn from the US market, the protocol was amended to alter the immunosuppressive regimen to abatacept for the study participants.

DRUG

Abatacept

Abatacept is drug used to treat autoimmune diseases. Abatacept is administered intravenously, monthly, in weight-based doses and is given for as long as transplanted islets are functioning.

DRUG

Belatacept

Belatacept is a medication to provide extended graft survival while limiting the toxicity generated by standard immune suppressing regimens. Belatacept is administered intravenously. The protocol for this study was amended to substitute belatacept for abatacept for all newly enrolling participants (current participants remained on abatacept).

Trial Locations (1)

30322

Emory University, Atlanta

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Emory University

OTHER