NCT02464878View on ClinicalTrials.gov

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

November 30, 2022

Study Completion Date

December 31, 2022

Conditions
Kidney TransplantType 1 Diabetes
Interventions
DRUG

Alpha 1-Antitrypsin

Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.

PROCEDURE

Islet Transplantation

DRUG

Thymoglobulin

Patients will receive a total of 5 doses between Day -2 and Day +2

DRUG

Basiliximab

Basiliximab will be used for subsequent transplants.

DRUG

Etanercept

Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

University of Iowa

OTHER

lead

Massachusetts General Hospital

OTHER

NCT02464878 - Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant | Biotech Hunter | Biotech Hunter